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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
  1.  K250805  DeVilbiss PulmO2 10-Liter Oxygen Concentrator (106 ...
  2.  K253549  DeVilbiss 5 Liter Oxygen Concentrator (555)
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
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
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 209 209

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 259 273
Adverse Event Without Identified Device or Use Problem 193 193
Fire 174 174
Thermal Decomposition of Device 149 149
Insufficient Information 135 139
No Flow 122 122
Low Readings 107 107
Use of Device Problem 100 100
Insufficient Flow or Under Infusion 89 89
Unexpected Shutdown 80 80
No Audible Alarm 72 72
Temperature Problem 65 65
Melted 60 74
Output Problem 59 59
Excessive Heating 58 58
Explosion 54 54
Unexpected Therapeutic Results 54 54
Smoking 53 53
Failure to Deliver 52 59
Noise, Audible 49 49
Electrical /Electronic Property Problem 47 47
Device Emits Odor 42 42
Improper or Incorrect Procedure or Method 36 36
Power Problem 35 35
Battery Problem 35 36
No Apparent Adverse Event 34 34
Contamination 32 32
Material Deformation 30 30
Improper Flow or Infusion 28 28
Mechanical Problem 28 28
Gas Output Problem 27 27
Infusion or Flow Problem 25 25
Failure to Power Up 24 24
Device Alarm System 22 22
Sparking 22 22
Degraded 21 21
Crack 20 20
Particulates 19 19
Failure to Charge 18 18
Appropriate Term/Code Not Available 16 16
Arcing 15 15
Gas/Air Leak 14 14
Complete Loss of Power 14 14
Device Contamination with Chemical or Other Material 13 13
Electrical Shorting 12 12
Therapeutic or Diagnostic Output Failure 12 18
Material Integrity Problem 11 11
Premature Discharge of Battery 11 11
Defective Alarm 10 10
Disconnection 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1147 1165
Low Oxygen Saturation 230 230
Dyspnea 172 175
Insufficient Information 172 172
Burn(s) 140 140
Hypoxia 74 74
No Consequences Or Impact To Patient 72 72
Unspecified Respiratory Problem 65 65
Partial thickness (Second Degree) Burn 59 59
Death 44 44
Chronic Obstructive Pulmonary Disease (COPD) 27 27
Superficial (First Degree) Burn 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
No Known Impact Or Consequence To Patient 24 31
Full thickness (Third Degree) Burn 23 23
Pain 16 16
No Patient Involvement 16 16
Headache 16 16
Dizziness 16 23
Pneumonia 13 14
Respiratory Insufficiency 12 12
Skin Inflammation/ Irritation 11 11
Swelling/ Edema 10 10
Patient Problem/Medical Problem 9 9
Aspiration/Inhalation 9 9
Fall 8 8
Hypersensitivity/Allergic reaction 8 8
Loss of consciousness 8 8
Cyanosis 7 7
Emotional Changes 7 7
Respiratory Failure 7 7
Discomfort 6 6
Burning Sensation 6 6
No Information 6 6
Distress 6 6
Inflammation 5 5
Muscle Weakness 5 5
Cognitive Changes 5 5
Respiratory Tract Infection 5 5
Unspecified Heart Problem 5 5
Fatigue 5 5
Confusion/ Disorientation 5 5
Unspecified Kidney or Urinary Problem 5 5
Erythema 5 5
Cough 5 5
Presyncope 4 4
Unspecified Infection 4 5
Sleep Dysfunction 4 4
Syncope/Fainting 4 4
Bruise/Contusion 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 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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