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IntelliCuff 951001

by Hamilton Medical AG

IntelliCuff 951001 is an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Hamilton Medical AG, cleared under FDA 510(k) K150893 on 29 Jan 2016 and listed in FDA GUDID since 13 Apr 2016 (UDI-DI 07630002800839), active as of 9 Nov 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K150893

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630002800839 UDI-DI Date13 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150893 Date29 Jan 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150893 decided 29 Jan 2016 Active
  • FDA GUDID UDI-DI 07630002800839 listed 13 Apr 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2625-2026 FDA Class II initiated 22 May 2026

    Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

    • Ongoing Z-0335-2018 FDA Class II initiated 20 Jun 2017

    Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

Timeline

4 dated events

  1. Cleared FDA 510(k) K150893
  2. Listed FDA GUDID 07630002800839
  3. Recall initiated FDA recalls Z-0335-2018
  4. Recall initiated FDA recalls Z-2625-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
IntelliCuff
Generic name
Endotracheal tube cuff inflator
Model / Ref / Catalog
951001
Primary DI / UDI-DI
07630002800839
510(k) Number
FDA product code
BSK
GMDN term
Endotracheal tube cuff inflator
Device class
Class II
Regulation number
868.5750
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Endotracheal tube cuff inflator

Similar devices

Other devices filed under FDA product code BSK (Cuff, Tracheal Tube, Inflatable).

Other devices from Hamilton Medical AG

See all devices from Hamilton Medical AG →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)