FDA product code · Anesthesiology · Class 2
CBK: Ventilator, Continuous, Facility Use
CBK is FDA's product code for "Ventilator, Continuous, Facility Use": a Class 2 device classified under 21 CFR 868.5895, reviewed by the Anesthesiology panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for CBK
Across 44 510(k) clearances under CBK decided from 2018-01-01 to 2026-10-06, the median was 266 days from FDA receipt to decision. Half took between 158 and 392 days, and 80% were decided within 433 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 158 |
| Median | 266 |
| 75th percentile | 392 |
| 80th percentile | 433 |
| 90th percentile | 537 |
| Slowest | 865 |
| Year | Median days | n |
|---|---|---|
| 2019 | 435 | 8 |
| 2020 | 176 | 5 |
| 2021 | 267 | 6 |
| 2023 | 309 | 5 |
| 2024 | 203 | 9 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
CBK in the public FDA record
| 510(k) clearances, all years | 505 |
|---|---|
| Device recalls | 323 |
| Establishment listings | 392 |
| GUDID device identifiers | 2,317 |
Counts of records, not of devices or events. Adverse event reports for CBK are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite CBK
15 FDA recognized consensus standards cite CBK, 2 of them recognized only in part, among them ISO 5359 Fourth edition 2014-10-01; ISO 18082 First edition 2014-06-15; ISO 80601-2-74 First edition 2017-05. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-129 ISO 5359 Fourth edition 2014-10-01 — Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
- 1-130 ISO 18082 First edition 2014-06-15 — Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
- 1-138 ISO 80601-2-74 First edition 2017-05 — Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 1-146 ISO 80601-2-12 Second edition 2020-02 — Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- 1-160 ISO 80601-2-84 First edition 2020-07 — Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
- 1-173 ISO 18562-1 Second edition 2024-03 (partial recognition) — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- 1-174 ISO 18562-2 Second edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- 1-175 ISO 18562-3 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- 1-176 ISO 18562-4 Second Edition 2024-03 — Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
- 1-177 ISO 80601-2-74 Second edition 2021-07 — Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 1-187 ISO 80601-2-12 Third edition 2023-11 — Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- 1-188 ISO 80601-2-84 Second edition 2023-11 — Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
- 1-189 ISO 4135 Fourth edition 2022-01 — Anaesthetic and respiratory equipment - Vocabulary
- 1-62 ISO 5356-1 Third edition 2004-05-15 — Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- 3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION (partial recognition) — Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.