FDA product code · Anesthesiology · Class 2
BSK: Cuff, Tracheal Tube, Inflatable
BSK is FDA's product code for "Cuff, Tracheal Tube, Inflatable": a Class 2 device classified under 21 CFR 868.5750, reviewed by the Anesthesiology panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for BSK
Across 11 510(k) clearances under BSK decided from 2018-01-01 to 2026-10-06, the median was 185 days from FDA receipt to decision. Half took between 142 and 248 days, and 80% were decided within 267 days. These are past clearances, not a forecast for a new submission.
| Fastest | 99 |
|---|---|
| 25th percentile | 142 |
| Median | 185 |
| 75th percentile | 248 |
| 80th percentile | 267 |
| 90th percentile | 328 |
| Slowest | 387 |
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.
BSK in the public FDA record
| 510(k) clearances, all years | 40 |
|---|
Counts of records, not of devices or events. Adverse event reports for BSK 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 BSK
2 FDA recognized consensus standards cite BSK, among them ISO 18082 First edition 2014-06-15; ISO 23371 First edition 2022-05. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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)]
- 1-192 ISO 23371 First edition 2022-05 — Anaesthetic and respiratory equipment - Cuff pressure indication control and regulation devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.