FDA product code CBK: Ventilator, Continuous, Facility Use
CBK is the FDA product code for ventilator, continuous, facility use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 505 510(k) submissions under CBK, 21 in the last five years, from 148 different applicants. The average 510(k) review took 175 days (median 127); 260 days on average over the last three years. FDA has posted 323 recalls for CBK devices, 110 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, Continuous, Facility Use |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for CBK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 280 |
| 2018 | 4 | 176 |
| 2019 | 8 | 379 |
| 2020 | 5 | 227 |
| 2021 | 6 | 275 |
| 2023 | 5 | 412 |
| 2024 | 9 | 254 |
| 2025 | 4 | 304 |
| 2026 | 3 | 223 |
Compare with all 510(k) review times · Search every CBK clearance
Top CBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Puritan Bennett Corp. | 33 | 2007-02-15 |
| Hamilton Medical AG | 25 | 2021-02-05 |
| Bird Products Corp. | 21 | 2004-03-17 |
| Newport Medical Instruments, Inc. | 17 | 2012-11-09 |
| Siemens Elema AB | 15 | 2001-12-18 |
143 more applicants have CBK clearances. See the full list in Caduvo.
Most recent CBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253647 | Draegerwerk AG & CO Kgaa | Evita (V800); Evita (V600) | 2026-05-07 | 168 |
| K252663 | Iconic Solutions by Murcia, SL | Inbentus Versatile | 2026-04-14 | 235 |
| K251888 | Hsiner Co., Ltd. | VPAP Pediatric Face Mask | 2026-03-12 | 265 |
| K232365 | Oconnell Regulatory Consultants, Inc. | Vivo 45 LS | 2025-12-19 | 865 |
| K252173 | Fisher & Paykel Healthcare, Ltd. | 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 | 2025-09-10 | 61 |
Recalls for CBK devices
323 product recalls in 189 recall events; 110 initiated in the last five years and 98 still open. Most recent: 2026-06-30.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 10 |
| 2019 | 16 |
| 2020 | 5 |
| 2021 | 29 |
| 2022 | 13 |
| 2023 | 33 |
| 2024 | 26 |
| 2025 | 8 |
| 2026 | 11 |
Frequently asked questions
What is FDA product code CBK?
CBK is the FDA product code for ventilator, continuous, facility use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is CBK?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBK?
Across 505 cleared submissions the average was 175 days from receipt to decision (median 127).
Which companies have the most CBK clearances?
Puritan Bennett Corp. (33); Hamilton Medical AG (25); Bird Products Corp. (21); Newport Medical Instruments, Inc. (17); Siemens Elema AB (15).
Have CBK devices been recalled?
Yes: 323 product recalls across 189 recall events; the most recent began 2026-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code CBK
- Run a recall and safety report across every CBK manufacturer
- Watch product code CBK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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