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
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLIGHT MEDICAL INNOVATIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 3
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICONIC SOLUTIONS BY MURCIA, SL
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201874  Servo-u Ventilator System 4.1, Servo-n Ventilator ...
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
2020 11096 11105
2021 13322 13333
2022 15974 15986
2023 24928 24932
2024 20336 20339
2025 14196 14199
2026 5111 5112

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12658 12658
Output Problem 12002 12006
Circuit Failure 7385 7385
Electrical /Electronic Property Problem 6333 6333
Battery Problem 5832 5832
Failure to Run on Battery 5151 5152
Failure to Recalibrate 4875 4875
No Display/Image 4277 4277
Failure to Calibrate 4171 4171
Defective Component 3861 3861
Failure of Device to Self-Test 3567 3568
Insufficient Flow or Under Infusion 3265 3265
Failure to Power Up 2909 2912
Gas/Air Leak 2752 2753
Degraded 2743 2754
Display or Visual Feedback Problem 2575 2575
Improper Flow or Infusion 2350 2350
Unexpected Shutdown 2054 2055
Failure to Charge 1957 1957
Power Problem 1775 1776
Insufficient Information 1651 1652
Contamination 1642 1642
Infusion or Flow Problem 1541 1541
Protective Measures Problem 1531 1531
No Flow 1396 1396
Failure to Deliver 1335 1336
Gas Output Problem 1220 1221
Decrease in Pressure 1184 1186
Leak/Splash 1035 1039
Device Sensing Problem 925 925
Pressure Problem 909 909
Calibration Problem 767 767
Device Displays Incorrect Message 747 747
Complete Loss of Power 726 726
Therapeutic or Diagnostic Output Failure 642 644
Computer Software Problem 628 628
Adverse Event Without Identified Device or Use Problem 618 619
Device Alarm System 444 444
Communication or Transmission Problem 434 434
Inadequate User Interface 415 415
Connection Problem 410 410
Application Program Problem 399 399
No Apparent Adverse Event 398 399
Use of Device Problem 381 381
Increase in Pressure 353 353
Loose or Intermittent Connection 305 307
False Positive Result 299 299
Tidal Volume Fluctuations 295 295
Unexpected Therapeutic Results 293 293
Fracture 291 293

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90025 90045
No Consequences Or Impact To Patient 4714 4714
No Patient Involvement 4179 4180
Insufficient Information 2121 2124
Low Oxygen Saturation 1071 1074
Unspecified Respiratory Problem 569 573
No Information 556 556
Headache 375 378
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 298 298
No Known Impact Or Consequence To Patient 290 290
Dizziness 269 269
Dyspnea 264 272
Respiratory Failure 181 181
Asthma 178 178
Cancer 167 168
Cardiac Arrest 159 159
Respiratory Insufficiency 142 142
Unspecified Kidney or Urinary Problem 141 142
Respiratory Tract Infection 129 132
Nausea 126 126
Hypoxia 108 110
Skin Inflammation/ Irritation 107 107
Vomiting 101 101
Death 92 95
Cough 91 91
Bradycardia 89 89
Inflammation 89 89
Ventilator Dependent 83 83
Sore Throat 77 79
Hypersensitivity/Allergic reaction 75 75
Respiratory Arrest 65 65
Unspecified Heart Problem 63 63
Pneumonia 58 58
Pneumothorax 57 57
Chronic Obstructive Pulmonary Disease (COPD) 55 55
Cyanosis 44 44
Unspecified Hepatic or Biliary Problem 36 36
Hypoventilation 34 34
Heart Failure/Congestive Heart Failure 32 32
Apnea 30 30
Discomfort 30 30
Increased Respiratory Rate 29 29
Low Blood Pressure/ Hypotension 26 26
Loss of consciousness 25 25
Tachycardia 24 24
Chest Pain 21 21
Respiratory Acidosis 19 19
Unspecified Eye / Vision Problem 18 18
Pulmonary Dysfunction 17 17
Stroke/CVA 15 15

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 Getinge Group Logistics America, LLC II Oct-09-2020
20 Getinge Usa Sales Inc II Aug-24-2022
21 Getinge Usa Sales Inc I Aug-22-2022
22 Hamilton Medical AG I Aug-19-2025
23 Hamilton Medical AG I Jun-18-2024
24 Hamilton Medical AG II Apr-25-2023
25 Hamilton Medical AG II Nov-18-2022
26 Hamilton Medical AG I Aug-19-2022
27 Hamilton Medical, Inc. I Sep-20-2023
28 Hamilton Medical, Inc. I Jul-21-2023
29 Hill-Rom Manufacturing, Inc. II Nov-24-2020
30 Maquet Critical Care AB I Jun-27-2025
31 Medtronic formerly Covidien I Apr-25-2022
32 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
33 Percussionaire Corporation I Jan-23-2025
34 Percussionaire Corporation I Jan-17-2024
35 Percussionaire Corporation I Jan-17-2024
36 Percussionaire Corporation II Nov-07-2023
37 Philips Respironics, Inc. I Apr-02-2026
38 Philips Respironics, Inc. I Mar-26-2026
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
-
-