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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
BELLUSCURA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAIRE, INC.
  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
INOGEN
  SUBSTANTIALLY EQUIVALENT 1
INOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
OXUS, INC.
  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
2021 194 194
2022 305 308
2023 357 361
2024 450 450
2025 616 616
2026 209 209

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 238 238
Adverse Event Without Identified Device or Use Problem 147 147
Thermal Decomposition of Device 136 136
Fire 128 128
Insufficient Information 122 126
No Flow 119 119
Low Readings 107 107
Use of Device Problem 90 90
Insufficient Flow or Under Infusion 87 87
No Audible Alarm 71 71
Unexpected Shutdown 70 70
Temperature Problem 62 62
Output Problem 58 58
Excessive Heating 58 58
Unexpected Therapeutic Results 54 54
Melted 53 53
Failure to Deliver 48 48
Noise, Audible 43 43
Smoking 43 43
Electrical /Electronic Property Problem 42 42
Device Emits Odor 40 40
Power Problem 33 33
Explosion 32 32
Contamination 32 32
Battery Problem 31 32
Material Deformation 29 29
Improper or Incorrect Procedure or Method 29 29
Improper Flow or Infusion 27 27
No Apparent Adverse Event 27 27
Mechanical Problem 26 26
Gas Output Problem 26 26
Failure to Power Up 23 23
Degraded 21 21
Sparking 21 21
Infusion or Flow Problem 20 20
Crack 20 20
Device Alarm System 19 19
Failure to Charge 18 18
Particulates 18 18
Appropriate Term/Code Not Available 15 15
Arcing 14 14
Gas/Air Leak 13 13
Complete Loss of Power 13 13
Device Contamination with Chemical or Other Material 12 12
Material Integrity Problem 11 11
Premature Discharge of Battery 11 11
Defective Alarm 9 9
Break 9 9
Intermittent Loss of Power 9 9
Electrical Shorting 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1138 1142
Low Oxygen Saturation 212 212
Insufficient Information 172 172
Dyspnea 170 173
Burn(s) 110 110
Hypoxia 73 73
Unspecified Respiratory Problem 65 65
Partial thickness (Second Degree) Burn 53 53
Chronic Obstructive Pulmonary Disease (COPD) 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Superficial (First Degree) Burn 20 20
Full thickness (Third Degree) Burn 19 19
Headache 16 16
Pain 15 15
Dizziness 14 14
Respiratory Insufficiency 12 12
Pneumonia 12 13
Skin Inflammation/ Irritation 10 10
Swelling/ Edema 10 10
Aspiration/Inhalation 9 9
Fall 8 8
Hypersensitivity/Allergic reaction 8 8
Emotional Changes 7 7
Respiratory Failure 7 7
Cyanosis 7 7
Discomfort 6 6
Distress 6 6
Fatigue 5 5
Unspecified Kidney or Urinary Problem 5 5
Cough 5 5
Unspecified Heart Problem 5 5
Loss of consciousness 5 5
Muscle Weakness 5 5
Respiratory Tract Infection 5 5
Cognitive Changes 5 5
Erythema 5 5
Burning Sensation 5 5
Confusion/ Disorientation 5 5
Heart Failure/Congestive Heart Failure 4 4
Anxiety 4 4
Viral Infection 4 4
Fever 4 4
Stroke/CVA 4 4
Unspecified Infection 4 5
Inflammation 4 4
Presyncope 4 4
Sleep Dysfunction 4 4
Syncope/Fainting 4 4
Epistaxis 3 3
No Consequences Or Impact To Patient 3 3

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 DeVilbiss Healthcare LLC II May-04-2023
5 DeVilbiss Healthcare LLC II Dec-19-2022
6 DeVilbiss Healthcare LLC II Nov-11-2022
7 Invacare Corporation III Jul-12-2022
8 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD I Jan-03-2025
9 Medical Depot Inc. I May-09-2025
10 Ohio Medical Corporation II Jun-13-2025
11 Philips Respironics, Inc. II Nov-07-2025
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