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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
HONSUN (NANTONG) 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
OXYTEK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K252965  Oxygen Concentrator (OX-5A, OX-5C)
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 310 310

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 263 263
Adverse Event Without Identified Device or Use Problem 149 149
Thermal Decomposition of Device 137 137
Fire 125 125
Insufficient Device Problem Information 124 128
No Flow 120 120
Low Readings 107 107
Insufficient Flow or Under Infusion 106 106
Use of Device Problem 90 90
Unexpected Shutdown 77 77
No Audible Alarm 70 70
Temperature Problem 62 62
Excessive Heating 61 61
Failure to Deliver 55 55
Output Problem 54 54
Unexpected Therapeutic Results 54 54
Melted 52 52
Noise, Audible 46 46
Smoking 45 45
Electrical /Electronic Property Problem 42 42
Device Emits Odor 40 40
Power Problem 34 34
Battery Problem 31 31
Contamination 31 31
Material Deformation 29 29
No Apparent Adverse Event 29 29
Improper or Incorrect Procedure or Method 28 28
Explosion 28 28
Improper Flow or Infusion 26 26
Gas Output Problem 26 26
Mechanical Problem 26 26
Failure to Charge 24 24
Failure to Power Up 23 23
Sparking 21 21
Degraded 21 21
Infusion or Flow Problem 21 21
Crack 20 20
Device Alarm System 19 19
Particulates 18 18
Arcing 15 15
Appropriate Device Problem Term/Code Not Available 15 15
Complete Loss of Power 14 14
Gas/Air Leak 13 13
Premature Discharge of Battery 13 13
Material Integrity Problem 11 11
Device Contamination with Chemical or Other Material 10 10
Break 9 9
Intermittent Loss of Power 9 9
Electrical Shorting 9 9
Circuit Failure 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1167 1171
Low Oxygen Saturation 244 244
Dyspnea 189 192
Insufficient Information 173 173
Burn(s) 116 116
Unspecified Respiratory Problem 74 74
Hypoxia 73 73
Partial thickness (Second Degree) Burn 54 54
Chronic Obstructive Pulmonary Disease (COPD) 27 27
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 24 24
Superficial (First Degree) Burn 21 21
Full thickness (Third Degree) Burn 19 19
Headache 17 17
Dizziness 16 16
Pain 15 15
Respiratory Insufficiency 12 12
Pneumonia 12 13
Fall 12 12
Swelling/ Edema 11 11
Skin Inflammation/ Irritation 10 10
Aspiration/Inhalation 9 9
Hypersensitivity/Allergic reaction 8 8
Cyanosis 8 8
Syncope/Fainting 7 7
Emotional Changes 7 7
Respiratory Failure 7 7
Confusion/ Disorientation 6 6
Discomfort 6 6
Burning Sensation 6 6
Distress 6 6
Cough 6 6
Respiratory Tract Infection 5 5
Unspecified Kidney or Urinary Problem 5 5
Cognitive Changes 5 5
Muscle Weakness/Atrophy 5 5
Loss of consciousness 5 5
Anxiety 5 5
Erythema 5 5
Fatigue 5 5
Epistaxis 5 5
Unspecified Heart Problem 5 5
Convulsion/Seizure 4 4
Unspecified Infection 4 5
Heart Failure/Congestive Heart Failure 4 4
Viral Infection 4 4
Presyncope 4 4
Fever 4 4
Sleep Dysfunction 4 4
Inflammation 4 4
Respiratory Arrest 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 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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