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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device generator, oxygen, portable
Regulation Description Portable oxygen generator.
Product CodeCAW
Regulation Number 868.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
3B MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BELLUSCURA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAIRE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN KYCARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INOGEN
  SUBSTANTIALLY EQUIVALENT 1
INOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MOLECULAR PRODUCTS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210371  Portable Oxygen Concentrator, model: P2-E6
  2.  K223379  Portable Oxygen Concentrator (Model: P2-E7, P2-E)
  3.  K230702  Portable Oxygen Concentrator (Model: P2-S4, P2-S3, ...
  4.  K242718  Portable Oxygen Concentrator (P2-TOC)
  5.  K251764  Oxygen Concentrator-P2-O5E
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K210371  Portable Oxygen Concentrator, model: P2-E6
  2.  K223379  Portable Oxygen Concentrator (Model: P2-E7, P2-E)
  3.  K230702  Portable Oxygen Concentrator (Model: P2-S4, P2-S3, ...
  4.  K242718  Portable Oxygen Concentrator (P2-TOC)
  5.  K251764  Oxygen Concentrator-P2-O5E
SHENZHEN HARVEYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 120 130
2020 125 143
2021 194 194
2022 305 308
2023 357 361
2024 450 450
2025 616 616
2026 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 246 260
Adverse Event Without Identified Device or Use Problem 190 190
Fire 172 172
Thermal Decomposition of Device 148 148
Insufficient Information 134 138
No Flow 110 110
Low Readings 107 107
Use of Device Problem 100 100
Unexpected Shutdown 73 73
No Audible Alarm 72 72
Insufficient Flow or Under Infusion 72 72
Temperature Problem 64 64
Output Problem 59 59
Melted 59 73
Unexpected Therapeutic Results 54 54
Excessive Heating 54 54
Explosion 54 54
Smoking 50 50
Noise, Audible 47 47
Failure to Deliver 46 53
Electrical /Electronic Property Problem 46 46
Device Emits Odor 42 42
Improper or Incorrect Procedure or Method 36 36
Power Problem 34 34
No Apparent Adverse Event 33 33
Battery Problem 32 33
Contamination 32 32
Material Deformation 30 30
Improper Flow or Infusion 28 28
Mechanical Problem 28 28
Gas Output Problem 27 27
Infusion or Flow Problem 25 25
Failure to Power Up 24 24
Device Alarm System 22 22
Degraded 20 20
Crack 20 20
Sparking 20 20
Particulates 19 19
Failure to Charge 17 17
Appropriate Term/Code Not Available 16 16
Arcing 15 15
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 13 13
Therapeutic or Diagnostic Output Failure 12 18
Electrical Shorting 11 11
Material Integrity Problem 11 11
Complete Loss of Power 11 11
Defective Alarm 10 10
Defective Component 10 10
Disconnection 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1127 1145
Low Oxygen Saturation 202 202
Insufficient Information 170 170
Dyspnea 152 155
Burn(s) 140 140
Hypoxia 73 73
No Consequences Or Impact To Patient 72 72
Unspecified Respiratory Problem 63 63
Partial thickness (Second Degree) Burn 58 58
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 27 27
Superficial (First Degree) Burn 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
No Known Impact Or Consequence To Patient 24 31
Full thickness (Third Degree) Burn 22 22
No Patient Involvement 16 16
Dizziness 16 23
Pain 16 16
Headache 15 15
Pneumonia 13 14
Respiratory Insufficiency 11 11
Skin Inflammation/ Irritation 11 11
Swelling/ Edema 10 10
Patient Problem/Medical Problem 9 9
Aspiration/Inhalation 9 9
Hypersensitivity/Allergic reaction 8 8
Respiratory Failure 7 7
Loss of consciousness 7 7
Emotional Changes 7 7
Fall 7 7
Distress 6 6
Burning Sensation 6 6
Cyanosis 6 6
Discomfort 6 6
No Information 6 6
Confusion/ Disorientation 5 5
Erythema 5 5
Respiratory Tract Infection 5 5
Cognitive Changes 5 5
Unspecified Kidney or Urinary Problem 5 5
Muscle Weakness 5 5
Inflammation 5 5
Cough 5 5
Fatigue 5 5
Unspecified Heart Problem 5 5
Heart Failure/Congestive Heart Failure 4 4
Anxiety 4 4
Myocardial Infarction 4 4
Viral Infection 4 4
Stroke/CVA 4 4

Recalls
Manufacturer Recall Class Date Posted
1 3B Medical, Inc. II Apr-15-2026
2 Caire, Inc. II Nov-15-2024
3 Caire, Inc. II May-19-2022
4 Caire, Inc. II Jan-13-2020
5 Caire, Inc. II Oct-30-2019
6 DeVilbiss Healthcare LLC II May-04-2023
7 DeVilbiss Healthcare LLC II Dec-19-2022
8 DeVilbiss Healthcare LLC II Nov-11-2022
9 Invacare Corporation III Jul-12-2022
10 Invacare Corporation II Dec-01-2020
11 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
12 Medical Depot Inc. I May-09-2025
13 Ohio Medical Corporation II Jun-13-2025
14 Philips Respironics, Inc. II Nov-07-2025
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