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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter
Regulation Description Oximeter.
Product CodeDQA
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
AVIDHRT, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BELUN TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BIOBEAT TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 2
BODIMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHRONISENSE MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
COFOE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HINLAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XIAOOU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEADTEK RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
MOVANO INC. DBA MOVANO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
OWLET BABYCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXIWEAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SEMPULSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEST ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BRAV ELECTRONIC TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SMALLSIGNAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YKD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIBEL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SUREPULSE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
VYVO TECHNOLOGY CORP.(VT)
  SUBSTANTIALLY EQUIVALENT 1
WESPER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 553 558
2022 478 485
2023 392 394
2024 545 545
2025 407 407
2026 484 484

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 501 505
Low Readings 330 332
Unexpected Shutdown 271 273
Device Alarm System 248 248
Sensing Intermittently 203 203
High Readings 195 195
Image Display Error/Artifact 141 141
Patient Device Interaction Problem 129 129
Failure to Analyze Signal 119 119
Incorrect, Inadequate or Imprecise Result or Readings 98 98
Temperature Problem 98 98
Inappropriate or Unexpected Reset 82 82
Corroded 69 69
Unable to Obtain Readings 64 64
Break 58 58
Erratic or Intermittent Display 53 53
Crack 42 42
Communication or Transmission Problem 39 39
Display or Visual Feedback Problem 36 36
Failure to Power Up 34 36
Insufficient Device Problem Information 30 30
No Audible Alarm 29 29
Contamination 27 27
Patient-Device Incompatibility 27 27
Loose or Intermittent Connection 26 26
Delayed Program or Algorithm Execution 25 25
Appropriate Device Problem Term/Code Not Available 24 24
No Apparent Adverse Event 24 24
Defective Device 22 22
No Display/Image 17 17
Defective Alarm 16 16
Noise, Audible 15 15
Device Damaged Prior to Use 15 15
Failure to Read Input Signal 14 14
Mechanical Problem 14 14
Material Split, Cut or Torn 14 14
Imprecise or Erratic Results 13 13
Battery Problem 12 12
Ambient Noise Problem 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Data Problem 10 10
Use of Device Problem 10 10
Defective Component 10 10
Peeled/Delaminated 9 9
Circuit Failure 9 9
Inaccurate Information 9 9
Failure to Sense 9 9
Failure to Run on Battery 9 9
Device Displays Incorrect Message 9 9
Computer Software Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2243 2254
Insufficient Information 264 265
Pressure Sore/Ulcer 67 67
Burn(s) 50 50
No Consequences Or Impact To Patient 49 49
Low Oxygen Saturation 38 38
No Patient Involvement 31 31
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 29 29
Unspecified Tissue Injury 24 25
Blister 22 22
Anxiety 18 18
Superficial (First Degree) Burn 12 12
Skin Inflammation/ Irritation 11 11
Erythema 10 10
Cardiac Arrest 9 9
Cyanosis 7 7
Electric Shock 7 7
Skin Discoloration 6 6
Hypoxia 6 6
Brain Injury 5 5
Pain 4 4
Ulcer 4 4
Skin Erosion 4 4
Inflammation 4 4
Bradycardia 4 4
Rash 3 3
Burning Sensation 3 3
Localized Skin Lesion 3 3
Respiratory Arrest 3 3
Skin Disorders 2 2
Ischemia 2 2
Chest Pain 2 3
Abrasion 2 2
Respiratory Failure 2 2
Ventilator Dependent 2 2
Partial thickness (Second Degree) Burn 2 2
Convulsion/Seizure 2 2
Bruise/Contusion 2 2
Skin Burning Sensation 2 2
Encephalopathy 2 2
Dyspnea 2 2
Apnea 2 2
Deformity/ Disfigurement 1 1
Distress 1 1
Diminished Pulse Pressure 1 1
Loss of consciousness 1 1
Drug Resistant Bacterial Infection 1 1
Skin Maceration 1 1
Hyperresponsive to stimuli 1 1
Joint Contracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics, Inc. II Oct-31-2024
2 Covidien II Jul-21-2025
3 Edan Diagnostics II Jan-22-2026
4 Masimo Corporation II Apr-12-2024
5 Masimo Corporation II Jun-21-2023
6 Nihon Kohden America Inc II Oct-30-2024
7 SUREPULSE MEDICAL LTD III Feb-12-2026
8 Zoe Medical Incorporated II Sep-10-2024
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