Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device ventilator, continuous, facility use
Regulation Description Continuous ventilator.
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
CORVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA., INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMAR S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 2
DRAGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER &PAYKEL HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  1.  K190533  Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-V ...
  2.  K241520  Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face ...
  3.  K241943  Mojo Full Face Non-Vented Mask; Veraseal 2 Full Fa ...
TELESAIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9100 9505
2020 11096 11105
2021 13322 13333
2022 15974 15986
2023 24928 24932
2024 20336 20339
2025 12968 12971

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 13446 13446
Output Problem 12112 12116
Circuit Failure 7898 7898
Battery Problem 6171 6205
Electrical /Electronic Property Problem 5678 5678
Failure to Recalibrate 5331 5331
Failure to Run on Battery 4786 4787
No Display/Image 4579 4579
Defective Component 3929 3929
Failure to Calibrate 3441 3707
Failure of Device to Self-Test 3237 3238
Failure to Power Up 3073 3076
Gas/Air Leak 2738 2739
Insufficient Flow or Under Infusion 2713 2713
Display or Visual Feedback Problem 2649 2649
Degraded 2417 2428
Failure to Charge 2311 2327
Improper Flow or Infusion 2278 2278
Unexpected Shutdown 2035 2035
Protective Measures Problem 1844 1883
Power Problem 1721 1764
Insufficient Information 1714 1715
Contamination 1653 1653
Infusion or Flow Problem 1564 1564
No Flow 1492 1492
Failure to Deliver 1384 1385
Decrease in Pressure 1187 1189
Gas Output Problem 1164 1165
Leak/Splash 1083 1087
Device Displays Incorrect Message 942 942
Pressure Problem 934 934
Therapeutic or Diagnostic Output Failure 824 826
Calibration Problem 750 750
Complete Loss of Power 740 740
Adverse Event Without Identified Device or Use Problem 642 643
Application Program Problem 564 564
Incorrect, Inadequate or Imprecise Result or Readings 555 555
Computer Software Problem 522 522
Device Alarm System 506 506
Inadequate User Interface 462 466
Communication or Transmission Problem 450 450
Device Sensing Problem 431 431
Use of Device Problem 423 423
Connection Problem 416 416
Increase in Pressure 364 364
No Apparent Adverse Event 362 363
Tidal Volume Fluctuations 339 339
Loose or Intermittent Connection 300 302
False Positive Result 291 291
Unexpected Therapeutic Results 285 285

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83937 83956
No Patient Involvement 8546 8547
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 2021 2024
Low Oxygen Saturation 1127 1130
No Known Impact Or Consequence To Patient 1036 1038
No Information 865 865
Unspecified Respiratory Problem 569 573
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 291 291
Dizziness 270 270
Dyspnea 263 271
Death 185 188
Respiratory Failure 182 182
Asthma 178 178
Cancer 167 168
Cardiac Arrest 157 157
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Skin Inflammation/ Irritation 107 107
Vomiting 102 102
Hypoxia 98 100
Cough 91 91
Inflammation 89 89
Bradycardia 89 89
Ventilator Dependent 84 84
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Pneumothorax 66 66
No Code Available 66 66
Unspecified Heart Problem 64 64
Respiratory Arrest 62 62
Pneumonia 56 56
Chronic Obstructive Pulmonary Disease (COPD) 54 54
Cyanosis 46 46
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 33 33
Heart Failure/Congestive Heart Failure 32 32
Discomfort 29 29
Apnea 29 29
Increased Respiratory Rate 29 29
Low Blood Pressure/ Hypotension 28 28
Tachycardia 25 25
Loss of consciousness 24 24
Chest Pain 21 21
Respiratory Distress 20 20
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I May-09-2025
2 Baxter Healthcare Corporation I Jan-16-2025
3 Baxter Healthcare Corporation I Oct-22-2024
4 Baxter Healthcare Corporation I Jun-26-2024
5 Baxter Healthcare Corporation I Feb-24-2023
6 Breas Medical, Inc. II Apr-15-2022
7 Covidien I Jun-09-2025
8 Covidien I Aug-02-2024
9 Covidien Llc I Dec-09-2021
10 Covidien Llc II Nov-06-2020
11 Draeger Medical, Inc. I Aug-18-2023
12 Draeger Medical, Inc. I Jul-08-2023
13 Draeger Medical, Inc. I Feb-24-2023
14 Draeger Medical, Inc. II Apr-04-2022
15 Draeger Medical, Inc. II Oct-14-2021
16 Draeger Medical, Inc. II May-28-2021
17 GE Healthcare, LLC I Jun-06-2022
18 GE Healthcare, LLC II Aug-24-2020
19 GE Healthcare, LLC II Dec-17-2019
20 Getinge Group Logistics America, LLC II Oct-09-2020
21 Getinge Usa Sales Inc II Aug-24-2022
22 Getinge Usa Sales Inc I Aug-22-2022
23 Hamilton Medical AG I Aug-19-2025
24 Hamilton Medical AG I Jun-18-2024
25 Hamilton Medical AG II Apr-25-2023
26 Hamilton Medical AG II Nov-18-2022
27 Hamilton Medical AG I Aug-19-2022
28 Hamilton Medical AG I Jul-11-2019
29 Hamilton Medical, Inc. I Sep-20-2023
30 Hamilton Medical, Inc. I Jul-21-2023
31 Hill-Rom Manufacturing, Inc. II Nov-24-2020
32 Maquet Critical Care AB I Jun-27-2025
33 Medtronic formerly Covidien I Apr-25-2022
34 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
35 Percussionaire Corporation I Jan-23-2025
36 Percussionaire Corporation I Jan-17-2024
37 Percussionaire Corporation I Jan-17-2024
38 Percussionaire Corporation II Nov-07-2023
39 Philips Respironics, Inc. I Nov-13-2024
40 Philips Respironics, Inc. I Sep-05-2024
41 Philips Respironics, Inc. I Apr-17-2024
42 Philips Respironics, Inc. II Jan-04-2024
43 Philips Respironics, Inc. II Jul-07-2023
44 Philips Respironics, Inc. I Jun-02-2023
45 Philips Respironics, Inc. I Apr-03-2023
46 Philips Respironics, Inc. I Jan-06-2023
47 Philips Respironics, Inc. I Mar-18-2022
48 Philips Respironics, Inc. I Jan-22-2022
49 Philips Respironics, Inc. II Aug-13-2021
50 Philips Respironics, Inc. I Jul-15-2021
51 Philips Respironics, Inc. I Feb-15-2020
52 ResMed Ltd. I Oct-23-2023
53 Ventec Life Systems, Inc. I Feb-26-2025
54 Ventec Life Systems, Inc. I Feb-23-2024
55 Ventec Life Systems, Inc. II Jun-21-2021
56 Vyaire Medical II Jun-15-2023
57 Vyaire Medical I Feb-16-2022
58 Vyaire Medical II Mar-04-2020
59 ZOLL Medical Corporation I Jun-20-2024
-
-