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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 2
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 2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG LONG YAO ELECTRONIC 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 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEADTEK RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MOVANO INC. DBA MOVANO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWLET BABY CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXIWEAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.L.P. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEMPULSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BERRY ELECTRONIC TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AEON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BRAV ELECTRONIC TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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 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 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RAYSINTONE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SINO-K 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 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
TRUE WEARABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
VYVO TECHNOLOGY CORP.(VT)
  SUBSTANTIALLY EQUIVALENT 1
WESPER INC.
  SUBSTANTIALLY EQUIVALENT 1
XINKANG MEDICAL INSTRUMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 426 430
2021 553 554
2022 478 483
2023 392 392
2024 545 545
2025 315 315

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 374 374
Low Readings 309 309
Sensing Intermittently 228 228
Device Alarm System 226 226
Unexpected Shutdown 224 224
High Readings 148 148
Patient Device Interaction Problem 132 132
Image Display Error/Artifact 126 126
Break 109 109
Failure to Analyze Signal 100 100
Temperature Problem 98 98
Inappropriate or Unexpected Reset 98 98
Crack 89 89
Incorrect, Inadequate or Imprecise Result or Readings 81 84
Corroded 72 72
Unable to Obtain Readings 66 66
Display or Visual Feedback Problem 55 55
Erratic or Intermittent Display 52 52
Communication or Transmission Problem 51 51
Appropriate Term/Code Not Available 45 45
Failure to Power Up 40 40
No Audible Alarm 39 39
Adverse Event Without Identified Device or Use Problem 31 32
Patient-Device Incompatibility 30 30
Circuit Failure 28 28
Defective Device 28 28
Insufficient Information 27 27
Contamination 27 27
Noise, Audible 26 26
No Apparent Adverse Event 25 25
Delayed Program or Algorithm Execution 23 23
Failure to Read Input Signal 21 21
Device Damaged Prior to Use 19 19
Device Displays Incorrect Message 18 22
No Display/Image 17 17
Use of Device Problem 17 17
Defective Component 17 17
Mechanical Problem 15 15
Battery Problem 15 16
Charging Problem 13 14
Computer Software Problem 13 13
Material Split, Cut or Torn 12 12
Application Program Freezes, Becomes Nonfunctional 12 12
Defective Alarm 11 11
Loose or Intermittent Connection 10 10
Device Sensing Problem 10 10
Failure to Run on Battery 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Inaccurate Information 9 9
Device Markings/Labelling Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1793 1796
No Consequences Or Impact To Patient 277 277
Insufficient Information 246 251
No Patient Involvement 141 141
Pressure Sores 74 74
Burn(s) 51 51
Low Oxygen Saturation 36 36
Unspecified Tissue Injury 22 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Blister 19 19
Death 13 13
Superficial (First Degree) Burn 11 11
Skin Inflammation/ Irritation 9 9
Hypoxia 7 7
Cardiac Arrest 7 7
No Known Impact Or Consequence To Patient 7 7
Erythema 7 7
Cyanosis 6 6
No Information 6 6
Skin Discoloration 6 6
Injury 6 6
Electric Shock 5 5
Ulcer 5 5
Rash 5 5
Skin Erosion 5 5
Inflammation 4 4
Brain Injury 3 3
Partial thickness (Second Degree) Burn 3 3
Bradycardia 3 3
Skin Burning Sensation 2 2
Bruise/Contusion 2 2
Respiratory Failure 2 2
Ventilator Dependent 2 2
Convulsion/Seizure 2 2
Tachycardia 2 2
Dyspnea 2 2
Burning Sensation 2 2
Skin Disorders 2 2
Burn, Thermal 2 2
Abrasion 2 2
Ischemia 2 2
Respiratory Arrest 2 2
High Oxygen Saturation 2 2
Encephalopathy 2 2
Chest Pain 1 2
Septic Shock 1 1
Swelling 1 1
Asthma 1 1
Pain 1 1
Anemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics, Inc. II Oct-31-2024
2 Covidien II Jul-21-2025
3 Masimo Corporation II Apr-12-2024
4 Masimo Corporation II Jun-21-2023
5 Nihon Kohden America Inc II Oct-30-2024
6 Zoe Medical Incorporated II Sep-10-2024
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