FDA product code · General Hospital · Class 2
CAH: Filter, Bacterial, Breathing-Circuit
CAH is FDA's product code for "Filter, Bacterial, Breathing-Circuit": a Class 2 device classified under 21 CFR 868.5260, reviewed by the General Hospital panel.
510(k) review time for CAH
Across 16 510(k) clearances under CAH decided from 2018-01-01 to 2026-10-06, the median was 257 days from FDA receipt to decision. Half took between 204 and 350 days, and 80% were decided within 375 days. These are past clearances, not a forecast for a new submission.
| Fastest | 167 |
|---|---|
| 25th percentile | 204 |
| Median | 257 |
| 75th percentile | 350 |
| 80th percentile | 375 |
| 90th percentile | 404 |
| Slowest | 507 |
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.
CAH in the public FDA record
| 510(k) clearances, all years | 202 |
|---|---|
| Device recalls | 28 |
| Establishment listings | 308 |
| GUDID device identifiers | 2,889 |
Counts of records, not of devices or events. Adverse event reports for CAH 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 CAH
7 FDA recognized consensus standards cite CAH, 1 of them recognized only in part, among them ISO 18562-1 Second edition 2024-03; ISO 18562-2 Second edition 2024-03; ISO 18562-3 Second Edition 2024-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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
- 1-190 ISO 9360-1 First edition 2000-03 — Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
- 1-191 ISO 9360-2 First edition 2001-07 — Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
- 1-62 ISO 5356-1 Third edition 2004-05-15 — Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.