TPLC - Total Product Life Cycle

• Device: continuous measurement thermometer
• Regulation Description: Clinical electronic thermometer.
• Definition: A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
• Product Code: FLL
• Regulation Number: 880.2910
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AION BIOSYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	2
ALICN MEDICAL SHENZHEN, INC
	SUBSTANTIALLY EQUIVALENT	3
ALICN MEDICAL SHENZHEN, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALICN MEDICAL SHENZHEN,INC
	SUBSTANTIALLY EQUIVALENT	1
ANDON HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOLAND TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOLAND TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUE SPARK TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
BODYCAP
	SUBSTANTIALLY EQUIVALENT	1
CIRCA SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
CIRCA SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONMO ELECTRONIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN E-TEST TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN XINTAI INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FAMIDOC TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GUANDONG GENIAL TECHNOLOGY CO., LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
GUANGZHOU DAXIN HEALTH TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HADLEIGH HEALTH TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU QINGYUAN MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALTH & LIFE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HEITAIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HETAIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HONSUN (NANTONG) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUAIAN ZHONGXIN PACKING MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBDIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN HONGGAO ELECTRONIC TECHNOLOFY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IWEECARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIAXING SHANGJIA INTELLIGENCE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JKH HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
JOYTECH HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KANGFU MEDICAL EQUIPMENT FACTORY
	SUBSTANTIALLY EQUIVALENT	1
KANGZHAN COMMUNICATION ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KAZ USA, INC., A HELEN OF TROY COMPANY
	SUBSTANTIALLY EQUIVALENT	1
LONGNAN RENZHONG MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETI
	SUBSTANTIALLY EQUIVALENT	1
METKO MEDIKAL VE TTBBI CIHAZLAR D1S TICARET LTD. STI
	SUBSTANTIALLY EQUIVALENT	1
MICROLIFE INTELLECTUAL PROPERTY GMBH
	SUBSTANTIALLY EQUIVALENT	2
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PHOENIX INNOVATIVE HEALTHCARE MANUFACTURERS PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
PUTIAN HANJIANG HUAFENG PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO YASEE MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADIANT INNOVATION INC.
	SUBSTANTIALLY EQUIVALENT	1
SENSATRONIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BITTEL INTELLIGENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHEN ZHEN RONG FENG TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN COMBEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ENVISEN INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN FINICARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUZHONG TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MEDKE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SONIDA DIGITAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN URION TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XUNWEI INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YI FANG BLISTER PACKAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN YOUKEDE MEDICAL EQUIPMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SMART TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STEADYSENSE GMBH
	SUBSTANTIALLY EQUIVALENT	1
T&R BIOFAB CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRULY INSTRUMENT LIMITED
	SUBSTANTIALLY EQUIVALENT	1
UNI-TREND TECHNOLOGY (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNI-TREND TECHNOLOGY(CHINA) CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WELLVII INC
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU YOSUN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN INTRETECH INC.
	SUBSTANTIALLY EQUIVALENT	1
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG RONGSHENG INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHONGSHAN JINLI ELECTRONIC WEIGHING  EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	53	58
2021	115	118
2022	142	142
2023	101	101
2024	118	118
2025	67	67

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	317	317
False Negative Result	103	103
Insufficient Information	31	31
Incorrect, Inadequate or Imprecise Result or Readings	29	37
Low Readings	23	23
Use of Device Problem	16	16
Adverse Event Without Identified Device or Use Problem	14	14
High Readings	11	11
Patient Device Interaction Problem	10	10
Appropriate Term/Code Not Available	8	8
Overheating of Device	7	7
Improper or Incorrect Procedure or Method	6	6
Incorrect Interpretation of Signal	6	6
Device Sensing Problem	6	6
Output Problem	5	5
Incorrect Measurement	5	5
Defective Device	4	4
Difficult to Insert	4	4
Electromagnetic Compatibility Problem	4	4
Temperature Problem	3	3
Break	3	3
Device Damaged Prior to Use	3	3
Loose or Intermittent Connection	3	3
Migration or Expulsion of Device	2	2
Loss of Power	2	2
Increased Sensitivity	2	2
Unable to Obtain Readings	2	2
High Test Results	2	2
Labelling, Instructions for Use or Training Problem	2	2
No Device Output	1	1
Loss of or Failure to Bond	1	1
Device Displays Incorrect Message	1	1
Display or Visual Feedback Problem	1	1
Inaccurate Information	1	1
Human-Device Interface Problem	1	1
Device Dislodged or Dislocated	1	1
Failure to Advance	1	1
Erratic or Intermittent Display	1	1
No Apparent Adverse Event	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Product Quality Problem	1	1
Material Deformation	1	1
Calibration Problem	1	1
Sharp Edges	1	1
Moisture or Humidity Problem	1	1
Failure to Power Up	1	1
Battery Problem	1	1
Contamination /Decontamination Problem	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	366	366
Fever	113	116
Insufficient Information	27	27
No Known Impact Or Consequence To Patient	17	22
Convulsion/Seizure	8	8
Viral Infection	8	8
Superficial (First Degree) Burn	7	7
No Consequences Or Impact To Patient	6	6
Foreign Body In Patient	6	6
Perforation	5	5
Laceration(s) of Esophagus	5	5
Alteration in Body Temperature	5	5
Hemorrhage/Bleeding	4	4
Burn(s)	4	4
Hypothermia	4	4
Sepsis	3	3
Unspecified Tissue Injury	3	3
Blood Loss	3	3
Burning Sensation	3	3
Injury	3	3
Distress	2	2
Fistula	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Arrhythmia	2	2
Cough	2	2
Gastritis	2	2
Anxiety	2	2
Epistaxis	2	2
Pain	2	2
Bronchitis	1	1
Sore Throat	1	1
Pressure Sores	1	1
Bacterial Infection	1	1
Partial thickness (Second Degree) Burn	1	1
Shaking/Tremors	1	1
Tachycardia	1	1
Nasal Obstruction	1	1
Pneumonia	1	1
Unspecified Kidney or Urinary Problem	1	1
No Patient Involvement	1	1
Discomfort	1	1
Rash	1	1
Oversedation	1	1
Irritation	1	1
Skin Discoloration	1	1
Autoimmune Disorder	1	1
Blister	1	1
Asthma	1	1
Abdominal Distention	1	1
Malaise	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Oct-23-2025
2	Baxter Healthcare Corporation	II	Jul-11-2024
3	Cardinal Health 200, LLC	II	Feb-04-2020
4	Welch Allyn Inc	II	Sep-16-2021