IntelliCuff— 510(k) K150893

Substantially Equivalent

Hamilton Medical AG

FDA 510(k) clearance K150893 for IntelliCuff, Substantially Equivalent on 2016-01-29. Applicant: Hamilton Medical AG. Device class: 2.

Clearance details

Applicant: Hamilton Medical AG
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2015-04-02
Decision date: 2016-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonaduz, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSK

K261499 — TrachFlush2026-08-13
K243562 — CuffGuard2025-08-12
K242642 — CuffTrek2025-03-07
K220854 — TrachCuff Cuff Controller2023-04-14
K221477 — AG100s2022-12-29

More clearances from Hamilton Medical AG

K201306 — HAMILTON-C32021-02-05
K201658 — Hamilton-C62020-12-11
K193228 — Hamilton-G52020-05-04
K181216 — HAMILTON-T1, HAMILTON-C12019-08-02
K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC40102017-09-20

Recalls naming K150893

K-number listed on FDA's recall record

Z-2625-2026 — IntelliCuff, Portable automatic cuff pressure controller REF: 951001Class II·Ongoing·Hamilton Medical AG·20260522
Z-0335-2018 — Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.Class II·Ongoing·Hamilton Medical, Inc.·20170620

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150893.

Data sourced from openFDA. This site is unofficial and independent of the FDA.