# K150893: IntelliCuff

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Jan 29, 2016 after 302 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912723 (1991). 6 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092733: PYTON, Arm Medical Devices, Inc. (2010) Summary page 5.

## Most influential descendants
- K220854: TrachCuff Cuff Controller (2023), 1 descendant of its own
- K261499: TrachFlush (2026), 0 descendants of its own
- K243562: CuffGuard (2025), 0 descendants of its own
- K221477: AG100s (2022), 0 descendants of its own
- K202874: Puritan Bennett Cuff Pressure Manager (2021), 0 descendants of its own

## Recalls of this device
- May 22, 2026 · Class II · Z-2625-2026: 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.
- Jun 20, 2017 · Class II · Z-0335-2018: Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

## Indications for use
The IntelliCuff device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The device can be used with any mechanical ventilator, as follows: When used with a non-Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set on the device. When used with a Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set either on the device or on the ventilator, depending on configuration. The device is to be used during ventilation of adults, pediatrics, and neonates, who are intubated with ETT or TT, in the following areas: In the intensive care ward or in the recovery room In the operation room during intubation narcosis For emergency medical care or primary care During transport within and outside of the hospital During transfer by rescue vehicles, ship, jet, or helicopter

Source page: https://510kreport.com/device/K150893
Methodology: https://510kreport.com/methodology