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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
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
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
MOLECULAR PRODUCTS 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
  1.  K210371  Portable Oxygen Concentrator, model: P2-E6
  2.  K223379  Portable Oxygen Concentrator (Model: P2-E7, P2-E)
  3.  K230702  Portable Oxygen Concentrator (Model: P2-S4, P2-S3, ...
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K210371  Portable Oxygen Concentrator, model: P2-E6
  2.  K223379  Portable Oxygen Concentrator (Model: P2-E7, P2-E)
  3.  K230702  Portable Oxygen Concentrator (Model: P2-S4, P2-S3, ...
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K210371  Portable Oxygen Concentrator, model: P2-E6
  2.  K223379  Portable Oxygen Concentrator (Model: P2-E7, P2-E)
  3.  K230702  Portable Oxygen Concentrator (Model: P2-S4, P2-S3, ...
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 120 120
2020 125 125
2021 194 194
2022 305 305
2023 357 361
2024 450 450
2025 214 214

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 164 164
Fire 148 148
Overheating of Device 145 145
Low Readings 107 107
Insufficient Information 88 92
Thermal Decomposition of Device 87 87
Use of Device Problem 85 85
No Flow 77 77
No Audible Alarm 71 71
Output Problem 57 57
Temperature Problem 55 55
Explosion 49 49
Melted 42 42
Noise, Audible 40 40
Unexpected Shutdown 40 40
Electrical /Electronic Property Problem 40 40
Smoking 37 37
Device Emits Odor 35 35
Insufficient Flow or Under Infusion 35 35
Material Deformation 29 29
Excessive Heating 29 29
Battery Problem 29 29
Improper or Incorrect Procedure or Method 28 28
Power Problem 28 28
Contamination 27 27
Gas Output Problem 26 26
Infusion or Flow Problem 23 23
Mechanical Problem 23 23
No Apparent Adverse Event 23 23
Failure to Deliver 22 22
Crack 20 20
Failure to Power Up 20 20
Device Alarm System 20 20
Particulates 19 19
Improper Flow or Infusion 19 19
Degraded 18 18
Sparking 16 16
Appropriate Term/Code Not Available 16 16
Gas/Air Leak 14 14
Failure to Charge 12 12
Device Contamination with Chemical or Other Material 12 12
Material Integrity Problem 11 11
Complete Loss of Power 11 11
Electrical Shorting 11 11
Disconnection 10 10
Therapeutic or Diagnostic Output Failure 10 10
Defective Alarm 10 10
Material Discolored 9 9
Break 9 9
Intermittent Loss of Power 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 876 880
Low Oxygen Saturation 129 129
Burn(s) 125 125
Insufficient Information 116 116
Dyspnea 74 74
No Consequences Or Impact To Patient 72 72
Hypoxia 60 60
Unspecified Respiratory Problem 50 50
Partial thickness (Second Degree) Burn 49 49
Death 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
No Known Impact Or Consequence To Patient 24 24
Chronic Obstructive Pulmonary Disease (COPD) 23 23
Full thickness (Third Degree) Burn 20 20
Superficial (First Degree) Burn 19 19
No Patient Involvement 16 16
Headache 12 12
Pneumonia 11 11
Swelling/ Edema 10 10
Aspiration/Inhalation 9 9
Skin Inflammation/ Irritation 9 9
Dizziness 9 9
Patient Problem/Medical Problem 9 9
Pain 8 8
Hypersensitivity/Allergic reaction 8 8
No Information 6 6
Distress 6 6
Discomfort 6 6
Erythema 5 5
Inflammation 5 5
Respiratory Failure 5 5
Respiratory Tract Infection 5 5
Burning Sensation 5 5
Unspecified Heart Problem 5 5
Unspecified Kidney or Urinary Problem 5 5
Muscle Weakness 5 5
Viral Infection 4 4
Loss of consciousness 4 4
Heart Failure/Congestive Heart Failure 4 4
Cough 4 4
Sleep Dysfunction 4 4
Cognitive Changes 4 4
Respiratory Insufficiency 4 4
Fall 4 4
Arthralgia 3 3
Anxiety 3 3
Epistaxis 3 3
Increased Sensitivity 3 3
Respiratory Distress 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
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