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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
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240840  Oxygen Concentrator (ZY-10AB/115)
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 1
LONGFIAN SCITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 499 499

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 200 214
Adverse Event Without Identified Device or Use Problem 173 173
Fire 163 163
Insufficient Information 125 129
Thermal Decomposition of Device 119 119
Low Readings 107 107
Use of Device Problem 90 90
No Flow 88 88
No Audible Alarm 71 71
Temperature Problem 60 60
Output Problem 58 58
Explosion 51 51
Melted 49 63
Electrical /Electronic Property Problem 45 45
Unexpected Shutdown 44 44
Noise, Audible 43 43
Insufficient Flow or Under Infusion 43 43
Smoking 41 41
Unexpected Therapeutic Results 41 41
Device Emits Odor 40 40
Excessive Heating 37 37
Contamination 32 32
Improper or Incorrect Procedure or Method 32 32
Power Problem 32 32
No Apparent Adverse Event 32 32
Material Deformation 30 30
Battery Problem 29 30
Improper Flow or Infusion 28 28
Mechanical Problem 27 27
Failure to Deliver 27 34
Gas Output Problem 26 26
Infusion or Flow Problem 25 25
Crack 20 20
Device Alarm System 20 20
Degraded 20 20
Failure to Power Up 20 20
Particulates 19 19
Appropriate Term/Code Not Available 16 16
Sparking 16 16
Gas/Air Leak 14 14
Device Contamination with Chemical or Other Material 13 13
Failure to Charge 13 13
Therapeutic or Diagnostic Output Failure 12 18
Electrical Shorting 11 11
Complete Loss of Power 11 11
Material Integrity Problem 11 11
Defective Alarm 10 10
Defective Component 10 10
Arcing 10 10
Disconnection 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1020 1038
Low Oxygen Saturation 147 147
Insufficient Information 147 147
Burn(s) 133 133
Dyspnea 120 123
Hypoxia 72 72
No Consequences Or Impact To Patient 72 72
Unspecified Respiratory Problem 55 55
Partial thickness (Second Degree) Burn 53 53
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 25 25
No Known Impact Or Consequence To Patient 24 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Full thickness (Third Degree) Burn 21 21
Superficial (First Degree) Burn 20 20
No Patient Involvement 16 16
Pain 15 15
Headache 13 13
Pneumonia 12 13
Swelling/ Edema 10 10
Dizziness 9 16
Skin Inflammation/ Irritation 9 9
Aspiration/Inhalation 9 9
Patient Problem/Medical Problem 9 9
Hypersensitivity/Allergic reaction 8 8
Emotional Changes 7 7
Respiratory Failure 7 7
Distress 6 6
No Information 6 6
Discomfort 6 6
Loss of consciousness 6 6
Respiratory Insufficiency 6 6
Unspecified Kidney or Urinary Problem 5 5
Unspecified Heart Problem 5 5
Respiratory Tract Infection 5 5
Inflammation 5 5
Muscle Weakness 5 5
Erythema 5 5
Burning Sensation 5 5
Cognitive Changes 5 5
Fall 4 4
Heart Failure/Congestive Heart Failure 4 4
Anxiety 4 4
Viral Infection 4 4
Cough 4 4
Sleep Dysfunction 4 4
Myocardial Infarction 4 4
Laceration(s) 3 3
Epistaxis 3 3
Confusion/ Disorientation 3 3

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