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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
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
  1.  K190304  Kingon P2 Oxygen Concentrator
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 310 310

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 283 283
Adverse Event Without Identified Device or Use Problem 194 194
Fire 167 167
Thermal Decomposition of Device 150 150
Insufficient Device Problem Information 137 141
No Flow 122 122
Insufficient Flow or Under Infusion 108 108
Low Readings 107 107
Use of Device Problem 100 100
Unexpected Shutdown 84 84
No Audible Alarm 71 71
Temperature Problem 65 65
Excessive Heating 61 61
Failure to Deliver 58 58
Melted 58 58
Output Problem 55 55
Unexpected Therapeutic Results 54 54
Smoking 54 54
Noise, Audible 51 51
Explosion 49 49
Electrical /Electronic Property Problem 47 47
Device Emits Odor 42 42
Power Problem 36 36
No Apparent Adverse Event 36 36
Battery Problem 35 35
Improper or Incorrect Procedure or Method 34 34
Contamination 31 31
Material Deformation 30 30
Mechanical Problem 28 28
Gas Output Problem 27 27
Improper Flow or Infusion 27 27
Infusion or Flow Problem 26 26
Failure to Charge 24 24
Failure to Power Up 23 23
Sparking 22 22
Degraded 21 21
Device Alarm System 20 20
Crack 20 20
Particulates 19 19
Arcing 16 16
Appropriate Device Problem Term/Code Not Available 16 16
Complete Loss of Power 15 15
Gas/Air Leak 14 14
Premature Discharge of Battery 13 13
Electrical Shorting 12 12
Material Integrity Problem 11 11
Device Contamination with Chemical or Other Material 10 10
Circuit Failure 9 9
Break 9 9
Charging Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1176 1194
Low Oxygen Saturation 262 262
Dyspnea 191 194
Insufficient Information 173 173
Burn(s) 146 146
Hypoxia 74 74
Unspecified Respiratory Problem 74 74
No Consequences Or Impact To Patient 72 72
Partial thickness (Second Degree) Burn 60 60
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 18 25
Headache 17 17
No Patient Involvement 16 16
Pain 16 16
Pneumonia 13 14
Respiratory Insufficiency 12 12
Fall 12 12
Skin Inflammation/ Irritation 11 11
Swelling/ Edema 11 11
Aspiration/Inhalation 9 9
Patient Problem/Medical Problem 9 9
Cyanosis 8 8
Loss of consciousness 8 8
Hypersensitivity/Allergic reaction 8 8
Emotional Changes 7 7
Syncope/Fainting 7 7
Burning Sensation 7 7
Respiratory Failure 7 7
Confusion/ Disorientation 6 6
Discomfort 6 6
Cough 6 6
No Information 6 6
Distress 6 6
Inflammation 5 5
Epistaxis 5 5
Unspecified Kidney or Urinary Problem 5 5
Cognitive Changes 5 5
Muscle Weakness/Atrophy 5 5
Respiratory Tract Infection 5 5
Anxiety 5 5
Erythema 5 5
Fatigue 5 5
Unspecified Heart Problem 5 5
Presyncope 4 4
Unspecified Infection 4 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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