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TPLC - Total Product Life Cycle
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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 CodeFLL
Regulation Number 880.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
AION BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALICN MEDICAL SHENZHEN, INC.
  SUBSTANTIALLY EQUIVALENT 6
ANDON HEALTH CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
COVIDIEN
  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
HETAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HONSUN (NANTONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN ZHONGXIN PACKING MATERIAL 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
JIAXING SHANGJIA INTELLIGENCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
KANGFU MEDICAL EQUIPMENT FACTORY
  SUBSTANTIALLY EQUIVALENT 1
KANGZHAN COMMUNICATION ELECTRONICS CO., LTD.
  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 1
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 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 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 2
WELLVII, INC.
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU YOSUN MEDICAL 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
2021 115 118
2022 142 142
2023 101 101
2024 118 118
2025 75 75
2026 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 317 317
False Negative Result 89 89
Incorrect, Inadequate or Imprecise Result or Readings 22 25
Low Readings 20 20
Incorrect Interpretation of Signal 17 17
Use of Device Problem 11 11
High Readings 11 11
Patient Device Interaction Problem 9 9
Insufficient Information 8 8
Appropriate Term/Code Not Available 7 7
Overheating of Device 7 7
Incorrect Measurement 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Device Sensing Problem 6 6
Output Problem 4 4
Electromagnetic Compatibility Problem 4 4
Difficult to Insert 4 4
Improper or Incorrect Procedure or Method 4 4
Failure to Sense 3 3
Loose or Intermittent Connection 3 3
Unable to Obtain Readings 3 3
Material Separation 2 2
Labelling, Instructions for Use or Training Problem 2 2
Break 2 2
Temperature Problem 2 2
Device Damaged Prior to Use 2 2
Increased Sensitivity 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Application Program Problem 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
High Test Results 1 1
Failure to Advance 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Moisture or Humidity Problem 1 1
Erratic or Intermittent Display 1 1
Migration or Expulsion of Device 1 1
No Device Output 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Failure to Analyze Signal 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 384 384
Fever 97 100
Insufficient Information 27 27
Convulsion/Seizure 9 9
Viral Infection 9 9
Superficial (First Degree) Burn 7 7
No Consequences Or Impact To Patient 6 6
Laceration(s) of Esophagus 5 5
Alteration in Body Temperature 5 5
Hypothermia 5 5
Perforation 4 4
Burn(s) 4 4
Foreign Body In Patient 4 4
Sepsis 3 3
Unspecified Tissue Injury 3 3
Burning Sensation 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
Bronchitis 1 1
Sore Throat 1 1
Pressure Sores 1 1
Hemorrhage/Bleeding 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
Pain 1 1
Discomfort 1 1
Rash 1 1
Oversedation 1 1
Skin Discoloration 1 1
Autoimmune Disorder 1 1
Localized Skin Lesion 1 1
Blister 1 1
Asthma 1 1
Abdominal Distention 1 1
Malaise 1 1
Hemoptysis 1 1
Hematoma 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Gastrointestinal Problem 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 Welch Allyn Inc II Sep-16-2021
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