CBKFDA Class 2 · 21 CFR 868.5895
Ventilator, Continuous, Facility Use
Device family · Anesthesiology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
504
Manufacturers
58
Flagged signals
15
Adverse-event reports
178,435
Code matrix
| FDA product code | CBK |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| GMDN | 35190, 35192 |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 9 | 90.7 | 712 |
| Other | 2011 | 4 | 40.3 | 117 |
| Death | 2010 | 6 | 15.8 | 70 |
| Death | 2020 | 3 | 14.8 | 26 |
| Death | 2016 | 4 | 10.6 | 26 |
| Death | 2010 | 3 | 10.3 | 17 |
| Other | 2011 | 5 | 8.7 | 27 |
| Other | 2010 | 3 | 5.2 | 6 |
| Death | 2017 | 11 | 5.2 | 33 |
| Death | 2016 | 10 | 4.7 | 26 |
| Death | 2013 | 13 | 3.9 | 25 |
| Death | 2015 | 11 | 3.3 | 15 |
| Injury | 2024 | 4 | 2.6 | 4 |
| Other | 2010 | 13 | 2.1 | 7 |
| Injury | 2015 | 7 | 2.0 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 178,435 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Puritan Bennett Corp. | 33 | 2007 | — |
| Hamilton Medical AG | 25 | 2021 | 0.40 |
| Newport Medical Instruments, Inc. | 17 | 2012 | — |
| Siemens Elema AB | 15 | 2001 | — |
| Respironics, Inc. | 14 | 2024 | — |
| Datex-Ohmeda, Inc. | 12 | 2021 | — |
| Hamilton Medical, Inc. | 10 | 2004 | — |
| Ohmeda Medical | 10 | 1996 | — |
| Maquet Critical Care AB | 9 | 2021 | — |
| BIO-MED DEVICES, INC. | 9 | 2018 | — |
| Draeger Medical, Inc. | 8 | 1998 | — |
| PERCUSSIONAIRE CORP. | 8 | 1991 | — |
| SECHRIST INDUSTRIES, INC. | 8 | 1999 | — |
| Respironics California, Inc. | 8 | 2012 | — |
| Acutronic Medical Systems AG | 6 | 2002 | — |
| Event Medical, Ltd. | 4 | 2013 | — |
| Ohio Medical Products | 4 | 1983 | — |
| Sleepnet Corporation | 4 | 2024 | — |
| Nellcor Puritan Bennett, Inc. | 4 | 2000 | — |
| Resmed, Ltd. | 4 | 2018 | — |
| Fisher & Paykel Healthcare, Ltd. | 3 | 2025 | — |
| NIHON KOHDEN ORANGEMED, INC. | 3 | 2023 | — |
| S & W Medico Teknik | 3 | 1992 | — |
| Siemens Medical Solutions USA, Inc. | 3 | 2002 | — |
| AIRON CORPORATION | 3 | 2012 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Inbentus Versatile · Iconic Solutions by Murcia, SL510(k) · 2026-04-14
VPAP Pediatric Face Mask · Hsiner Co., Ltd.510(k) · 2026-03-12
Vivo 45 LS · Oconnell Regulatory Consultants, Inc.510(k) · 2025-12-19
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full · Fisher & Paykel Healthcare, Ltd.510(k) · 2025-09-10
SV600, SV800 Ventilator · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.510(k) · 2025-08-28
AVEA disposable expiratory filter/water trap (11790) · Telesair, Inc.510(k) · 2025-05-08
AF531 Oro-Nasal SE Face Mask · Respironics, Inc.510(k) · 2024-12-30
731 Series Ventilator · ZOLL Medical Corporation510(k) · 2024-12-13
Ventoux VC2; Ventoux VC3 · Flight Medical Innovations , Ltd.510(k) · 2024-12-02
RESPOND(R) Ventilator · Corvent Medical, Inc.510(k) · 2024-11-13
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask · Sleepnet Corporation510(k) · 2024-08-28
Family of DIMAR DMAX NIV masks · Dimar S.P.A.510(k) · 2024-08-14
VM-2000 · Ventis Medical, Inc.510(k) · 2024-08-13
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask · Sleepnet Corporation510(k) · 2024-06-27
Nihon Kohden NKV-550 Series Ventilator System · Nihon Kohden Orangemed, LLC510(k) · 2024-03-01
Panther 5 · Origin Medical Devices510(k) · 2023-07-20
Mindray SV600 Ventilator, Mindray SV800 Ventilator · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.510(k) · 2023-06-16
Nihon Kohden NKV-440 Ventilator System · Nihon Kohden Orangemed, Inc.510(k) · 2023-05-31
Evita V800, Evita V600 · Draegerwerk AG & CO Kgaa510(k) · 2023-05-16
Babylog VN800, Babylog VN600 · Draegerwerk AG & CO Kgaa510(k) · 2023-05-16
LTV2 Series Ventilators · Vyaire Medical, Inc.510(k) · 2021-11-10
CARESCAPE R860 · Datex-Ohmeda, Inc.510(k) · 2021-11-04
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 · Maquet Critical Care AB510(k) · 2021-04-20
F&P Visairo NIV Mask Range · Fisher & Paykel Healthcare, Ltd.510(k) · 2021-04-14
HAMILTON-C3 · Hamilton Medical AG510(k) · 2021-02-05
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.