Product code BSK: 510(k) clearances and predicates
Product code BSK covers tracheal and endotracheal cuff pressure monitors and inflators. This page lists what the code covers and recent clearances by K number. Review timing is labeled insufficient data, not estimated.
Clearance volume
BSK is a sparse code. The trailing 24 month window holds 3 decisions, which is below the 10 decision minimum for a timeline. All time records live in the FDA 510(k) index under regulation 868.5750.
Clearance timeline
Review timing: insufficient data for BSK (fewer than 10 trailing decisions, n=3). We label sparse codes instead of inventing timelines.
What BSK covers
Product code BSK covers tracheal cuff pressure managers, cuff inflators, and cuff controllers (regulation 868.5750, Anesthesiology). Recent BSK clearances include TrachCuff Cuff Controller and Puritan Bennett Cuff Pressure Manager. Use the K numbers below as starting candidates and verify any predicate claim against the official 510(k) summary.
Recent clearances
Recent BSK clearances in the FDA index we track, with applicant and decision date:
- K220854, TrachCuff Cuff Controller, applicant Aw Technologies Aps, decided 2023-04-14. FDA record
- K202874, Puritan Bennett Cuff Pressure Manager, applicant Covidien, LLC, decided 2021-01-09. FDA record
- K102674, CUFF SENTRY, applicant Ventlab Corp., decided 2011-07-22. FDA record
What this means for a regulatory watcher
A sparse code gives you a short list of candidate predicates. Read each summary closely, since one recall or design gap removes a large share of the pool. Watch new BSK clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
Run the free check for BSK to see the latest clearances without signing up.
FAQ
What is FDA product code BSK?
It is the three letter code FDA assigns to tracheal cuff pressure devices in the 510(k) index. Recent BSK clearances include cuff controllers and cuff pressure managers.
How long does a BSK 510(k) take?
Insufficient data. Fewer than 10 trailing decisions exist (n=3), so no median or p90 is shown. We label sparse codes instead of inventing timelines.
How do I find a predicate device under BSK?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new BSK clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts. Or check BSK free first.
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Data: U.S. FDA via openFDA (public domain). Benchmarks computed 2026-09-27. Not regulatory advice. Assume all results are unvalidated.
Last updated 2026-10-12.