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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BELUN TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 3
BIOBEAT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
HANCOCK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XIAOOU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 8
MOVANO INC. DBA MOVANO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
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 CAREMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 UPNMED EQUIPMENT 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
  1.  K240092  Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, ...
SHENZHEN YIMI LIFE-TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIBEL HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
SPRY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SUREPULSE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
TAIWAN BIOPHOTONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUE WEARABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2019 548 548
2020 426 426
2021 553 553
2022 479 479
2023 392 392
2024 516 516

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 411 411
Low Readings 360 360
Sensing Intermittently 278 278
Device Alarm System 187 187
Unexpected Shutdown 171 171
High Readings 158 158
Display or Visual Feedback Problem 128 128
Inappropriate or Unexpected Reset 118 118
Patient Device Interaction Problem 118 118
Break 116 116
Image Display Error/Artifact 106 106
Temperature Problem 89 89
Crack 89 89
Incorrect, Inadequate or Imprecise Result or Readings 77 77
Failure to Analyze Signal 74 74
Corroded 72 72
Unable to Obtain Readings 53 53
Contamination /Decontamination Problem 52 52
Erratic or Intermittent Display 47 47
Communication or Transmission Problem 45 45
No Audible Alarm 43 43
Appropriate Term/Code Not Available 41 41
Failure to Power Up 33 33
Adverse Event Without Identified Device or Use Problem 32 32
Noise, Audible 30 30
Patient-Device Incompatibility 30 30
Circuit Failure 28 28
Contamination 27 27
Defective Device 25 25
Insufficient Information 25 25
No Apparent Adverse Event 23 23
Device Displays Incorrect Message 21 21
Failure to Read Input Signal 21 21
Device Damaged Prior to Use 19 19
Poor Quality Image 19 19
Delayed Program or Algorithm Execution 19 19
Mechanical Problem 19 19
Battery Problem 19 19
No Display/Image 18 18
Use of Device Problem 16 16
Defective Component 16 16
Computer Software Problem 14 14
Loose or Intermittent Connection 13 13
Charging Problem 13 13
Failure to Sense 13 13
Defective Alarm 13 13
Material Integrity Problem 12 12
Material Split, Cut or Torn 12 12
Display Difficult to Read 11 11
Output Problem 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1527 1527
No Consequences Or Impact To Patient 662 662
Insufficient Information 200 200
No Patient Involvement 184 184
Pressure Sores 88 88
Burn(s) 62 62
Low Oxygen Saturation 32 32
Death 32 32
No Known Impact Or Consequence To Patient 24 24
Injury 23 23
Unspecified Tissue Injury 21 21
Blister 17 17
No Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Superficial (First Degree) Burn 11 11
Skin Irritation 9 9
Erythema 7 7
Ulcer 6 6
Rash 6 6
Skin Discoloration 6 6
Hypoxia 5 5
Skin Inflammation/ Irritation 5 5
Laceration(s) 5 5
Burn, Thermal 5 5
Tissue Damage 4 4
Skin Erosion 4 4
Cardiac Arrest 4 4
Inflammation 4 4
Cyanosis 4 4
Bruise/Contusion 3 3
Electric Shock 3 3
Partial thickness (Second Degree) Burn 3 3
Burning Sensation 2 2
Skin Disorders 2 2
Skin Burning Sensation 2 2
Abrasion 2 2
Dyspnea 2 2
Pain 2 2
Bradycardia 2 2
Respiratory Failure 2 2
Ventilator Dependent 2 2
Tachycardia 2 2
High Oxygen Saturation 2 2
Convulsion/Seizure 2 2
Increased Sensitivity 1 1
Bronchopneumonia 1 1
Unintended Extubation 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1
Low Blood Pressure/ Hypotension 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 Xhale Assurance, Inc. II Jul-30-2019
6 Zoe Medical Incorporated II Sep-10-2024
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