# IntelliCuff 951001

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/intellicuff-951001>
- Manufacturer: [Hamilton Medical AG](https://devicerts.com/manufacturers/hamilton-medical-ag) (Switzerland)
- Device class: Class II (US FDA)
- FDA product code: BSK
- GMDN: Endotracheal tube cuff inflator (35401)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 07630002800839 · listed 2016-04-13 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K150893 · decision 2016-01-29 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2625-2026 · Class II · ongoing · initiated 2026-05-22: 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.
- Z-0335-2018 · Class II · ongoing · initiated 2017-06-20: Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

## Identity

- Trade name: IntelliCuff [FDA GUDID (AccessGUDID)]
- Generic name: Endotracheal tube cuff inflator [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 951001 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07630002800839 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K150893 [FDA GUDID (AccessGUDID)]
- FDA product code: BSK [FDA GUDID (AccessGUDID)]
- GMDN term: Endotracheal tube cuff inflator (35401) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 868.5750 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: IntelliCuff 951001, Hamilton Medical AG. deviCERTS medical device catalogue. https://devicerts.com/devices/intellicuff-951001 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-09
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/intellicuff-951001.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/intellicuff-951001
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.