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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
  1.  K240840  Oxygen Concentrator (ZY-10AB/115)
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
HONSUN (NANTONG) 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
MV LIFE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXYTEK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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 377 377

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 304 304
Adverse Event Without Identified Device or Use Problem 194 194
Fire 170 170
Thermal Decomposition of Device 155 155
Insufficient Device Problem Information 141 145
No Flow 129 129
Insufficient Flow or Under Infusion 123 123
Low Readings 107 107
Use of Device Problem 101 101
Unexpected Shutdown 93 93
No Audible Alarm 72 72
Temperature Problem 65 65
Failure to Deliver 64 64
Excessive Heating 61 61
Melted 58 58
Smoking 57 57
Output Problem 56 56
Unexpected Therapeutic Results 54 54
Noise, Audible 52 52
Explosion 49 49
Electrical /Electronic Property Problem 47 47
Device Emits Odor 42 42
Battery Problem 38 38
Power Problem 36 36
No Apparent Adverse Event 36 36
Improper or Incorrect Procedure or Method 34 34
Material Deformation 31 31
Contamination 31 31
Failure to Charge 29 29
Mechanical Problem 28 28
Improper Flow or Infusion 27 27
Gas Output Problem 27 27
Infusion or Flow Problem 26 26
Sparking 24 24
Failure to Power Up 24 24
Degraded 21 21
Crack 20 20
Device Alarm System 20 20
Particulates 19 19
Appropriate Device Problem Term/Code Not Available 16 16
Arcing 16 16
Complete Loss of Power 15 15
Premature Discharge of Battery 14 14
Gas/Air Leak 14 14
Electrical Shorting 12 12
Material Integrity Problem 11 11
Device Contamination with Chemical or Other Material 11 11
Break 10 10
Defective Component 9 9
Defective Alarm 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1201 1219
Low Oxygen Saturation 283 283
Dyspnea 206 209
Insufficient Information 178 178
Burn(s) 147 147
Unspecified Respiratory Problem 76 76
Hypoxia 75 75
No Consequences Or Impact To Patient 72 72
Partial thickness (Second Degree) Burn 61 61
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 27 27
Superficial (First Degree) Burn 25 25
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 24 24
No Known Impact Or Consequence To Patient 24 31
Full thickness (Third Degree) Burn 23 23
Dizziness 19 26
Headache 17 17
No Patient Involvement 16 16
Pain 16 16
Fall 13 13
Pneumonia 13 14
Respiratory Insufficiency 12 12
Swelling/ Edema 11 11
Skin Inflammation/ Irritation 11 11
Cyanosis 9 9
Patient Problem/Medical Problem 9 9
Syncope/Fainting 9 9
Aspiration/Inhalation 9 9
Hypersensitivity/Allergic reaction 8 8
Loss of consciousness 8 8
Burning Sensation 7 7
Fatigue 7 7
Emotional Changes 7 7
Respiratory Failure 7 7
No Information 6 6
Cough 6 6
Confusion/ Disorientation 6 6
Distress 6 6
Discomfort 6 6
Presyncope 5 5
Myocardial Infarction 5 5
Inflammation 5 5
Unspecified Heart Problem 5 5
Anxiety 5 5
Cognitive Changes 5 5
Unspecified Kidney or Urinary Problem 5 5
Epistaxis 5 5
Respiratory Tract Infection 5 5
Erythema 5 5
Muscle Weakness/Atrophy 5 5

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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