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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
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
GABI SMARTCARE SA
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG LONG YAO ELECTRONIC TECHNOLOGY CO., LTD.
  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
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 3
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 426 426
2021 553 553
2022 479 479
2023 392 392
2024 545 545
2025 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 326 326
Low Readings 290 290
Sensing Intermittently 216 216
Unexpected Shutdown 185 185
Device Alarm System 174 174
High Readings 136 136
Patient Device Interaction Problem 122 122
Break 107 107
Image Display Error/Artifact 98 98
Inappropriate or Unexpected Reset 95 95
Temperature Problem 92 92
Crack 89 89
Failure to Analyze Signal 79 79
Corroded 72 72
Incorrect, Inadequate or Imprecise Result or Readings 71 71
Display or Visual Feedback Problem 55 55
Unable to Obtain Readings 53 53
Erratic or Intermittent Display 49 49
Communication or Transmission Problem 47 47
Appropriate Term/Code Not Available 42 42
Failure to Power Up 33 33
Adverse Event Without Identified Device or Use Problem 30 30
Patient-Device Incompatibility 30 30
Circuit Failure 28 28
No Audible Alarm 28 28
Contamination 27 27
Noise, Audible 25 25
No Apparent Adverse Event 24 24
Defective Device 24 24
Insufficient Information 24 24
Delayed Program or Algorithm Execution 22 22
Failure to Read Input Signal 21 21
Device Displays Incorrect Message 18 18
Device Damaged Prior to Use 17 17
Defective Component 16 16
Use of Device Problem 15 15
Mechanical Problem 15 15
No Display/Image 15 15
Computer Software Problem 13 13
Charging Problem 13 13
Material Split, Cut or Torn 12 12
Defective Alarm 10 10
Loose or Intermittent Connection 10 10
Battery Problem 10 10
Device Markings/Labelling Problem 9 9
Display Difficult to Read 9 9
Material Separation 8 8
Failure to Run on Battery 8 8
Inaccurate Information 8 8
Ambient Noise Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1580 1580
No Consequences Or Impact To Patient 277 277
Insufficient Information 220 220
No Patient Involvement 141 141
Pressure Sores 70 70
Burn(s) 48 48
Low Oxygen Saturation 30 30
Unspecified Tissue Injury 22 22
Blister 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Death 13 13
Superficial (First Degree) Burn 11 11
Erythema 7 7
No Known Impact Or Consequence To Patient 7 7
No Information 6 6
Skin Inflammation/ Irritation 6 6
Injury 6 6
Skin Discoloration 6 6
Ulcer 5 5
Hypoxia 5 5
Rash 5 5
Cardiac Arrest 5 5
Inflammation 4 4
Skin Erosion 4 4
Partial thickness (Second Degree) Burn 3 3
Electric Shock 3 3
Cyanosis 3 3
Respiratory Failure 2 2
Skin Disorders 2 2
Burn, Thermal 2 2
Burning Sensation 2 2
Abrasion 2 2
Bruise/Contusion 2 2
Ventilator Dependent 2 2
Dyspnea 2 2
Bradycardia 2 2
Skin Burning Sensation 2 2
Tachycardia 2 2
Convulsion/Seizure 2 2
High Oxygen Saturation 2 2
Low Blood Pressure/ Hypotension 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1
Unintended Extubation 1 1
Deformity/ Disfigurement 1 1
Respiratory Distress Syndrome of Newborns 1 1
Bronchopneumonia 1 1
Joint Contracture 1 1
Increased Sensitivity 1 1
Hyperventilation 1 1

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