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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
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 1
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 8
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 408 408
2026 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 405 409
Low Readings 277 279
Unexpected Shutdown 242 244
Device Alarm System 224 224
Sensing Intermittently 191 191
High Readings 160 160
Image Display Error/Artifact 130 130
Patient Device Interaction Problem 118 118
Failure to Analyze Signal 101 101
Incorrect, Inadequate or Imprecise Result or Readings 101 104
Temperature Problem 94 94
Unable to Obtain Readings 81 81
Inappropriate or Unexpected Reset 69 69
Corroded 69 69
Break 61 61
Erratic or Intermittent Display 53 53
Crack 42 42
Communication or Transmission Problem 40 40
Failure to Power Up 34 36
Display or Visual Feedback Problem 33 33
Insufficient Information 31 31
Defective Device 28 28
Contamination 27 27
Adverse Event Without Identified Device or Use Problem 27 28
Patient-Device Incompatibility 27 27
No Audible Alarm 26 26
Loose or Intermittent Connection 26 26
Appropriate Term/Code Not Available 25 25
No Apparent Adverse Event 24 24
Delayed Program or Algorithm Execution 24 24
Failure to Read Input Signal 16 16
No Display/Image 16 16
Device Damaged Prior to Use 15 15
Battery Problem 15 16
Noise, Audible 15 15
Mechanical Problem 14 14
Use of Device Problem 13 13
Material Split, Cut or Torn 13 13
Defective Component 13 13
Erratic Results 11 11
Application Program Freezes, Becomes Nonfunctional 10 10
Defective Alarm 10 10
Device Sensing Problem 10 10
Circuit Failure 9 9
Failure to Run on Battery 9 9
Ambient Noise Problem 9 9
Device Displays Incorrect Message 9 9
Inaccurate Information 9 9
Charging Problem 9 10
Data Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1963 1974
Insufficient Information 246 247
Pressure Sores 64 64
No Consequences Or Impact To Patient 49 49
Burn(s) 47 47
Low Oxygen Saturation 37 37
No Patient Involvement 31 31
Unspecified Tissue Injury 23 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Blister 20 20
Anxiety 18 18
Superficial (First Degree) Burn 12 12
Erythema 9 9
Cardiac Arrest 9 9
Skin Inflammation/ Irritation 9 9
Skin Discoloration 6 6
Cyanosis 6 6
Brain Injury 5 5
Electric Shock 5 5
Hypoxia 5 5
Inflammation 4 4
Skin Erosion 4 4
Pain 4 4
Ulcer 4 4
Respiratory Arrest 3 3
Bradycardia 3 3
Ischemia 2 2
Skin Burning Sensation 2 2
Skin Disorders 2 2
Abrasion 2 2
Bruise/Contusion 2 2
Rash 2 2
Ventilator Dependent 2 2
Respiratory Failure 2 2
Dyspnea 2 2
Apnea 2 2
Encephalopathy 2 2
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Increased Sensitivity 1 1
Bronchopneumonia 1 1
Distress 1 1
Full thickness (Third Degree) Burn 1 1
Angioedema 1 1
Respiratory Distress Syndrome of Newborns 1 1
Deformity/ Disfigurement 1 1
Unspecified Respiratory Problem 1 1
Joint Contracture 1 1
Tachycardia 1 1
Nodule 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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