FDA product code BSK: Cuff, Tracheal Tube, Inflatable
BSK is the FDA product code for cuff, tracheal tube, inflatable. It is a Class II device, regulated under 21 CFR 868.5750 and reviewed by the Anesthesiology panel. FDA has cleared 40 510(k) submissions under BSK, 5 in the last five years, from 33 different applicants. The average 510(k) review took 164 days (median 144); 162 days on average over the last three years. FDA has posted 4 recalls for BSK devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cuff, Tracheal Tube, Inflatable |
| Device class | Class II |
| Regulation | 21 CFR 868.5750 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BSK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 166 |
| 2019 | 1 | 130 |
| 2020 | 2 | 278 |
| 2021 | 1 | 103 |
| 2022 | 1 | 220 |
| 2023 | 1 | 387 |
| 2025 | 2 | 226 |
| 2026 | 1 | 99 |
Compare with all 510(k) review times · Search every BSK clearance
Top BSK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hospitech Respiration , Ltd. | 4 | 2022-12-29 |
| Instrumentation Industries, Inc. | 3 | 2012-01-26 |
| Aw Technologies Aps | 2 | 2026-08-13 |
| Tracoe Medical GmbH | 2 | 2016-12-21 |
| Idmed | 1 | 2025-08-12 |
28 more applicants have BSK clearances. See the full list in Caduvo.
Most recent BSK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261499 | Aw Technologies Aps | TrachFlush | 2026-08-13 | 99 |
| K243562 | Idmed | CuffGuard | 2025-08-12 | 267 |
| K242642 | Shanghai Longmann Tech Co., Ltd. | CuffTrek | 2025-03-07 | 185 |
| K220854 | Aw Technologies Aps | TrachCuff Cuff Controller | 2023-04-14 | 387 |
| K221477 | Hospitech Respiration , Ltd. | AG100s | 2022-12-29 | 220 |
Recalls for BSK devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2026-05-22.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code BSK?
BSK is the FDA product code for cuff, tracheal tube, inflatable. It is a Class II device, regulated under 21 CFR 868.5750 and reviewed by the Anesthesiology panel.
What device class is BSK?
Class II, regulation 21 CFR 868.5750. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSK?
Across 40 cleared submissions the average was 164 days from receipt to decision (median 144).
Which companies have the most BSK clearances?
Hospitech Respiration , Ltd. (4); Instrumentation Industries, Inc. (3); Aw Technologies Aps (2); Tracoe Medical GmbH (2); Idmed (1).
Have BSK devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2026-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code BSK
- Run a recall and safety report across every BSK manufacturer
- Watch product code BSK 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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