# K182548: Accucuff Cuff Pressure Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Medis Medical Device Co., Ltd.
- Decided: Jan 25, 2019 after 130 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K903730 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142103: Cuff Pilot, Sure Seal, Teleflexmedical, Inc. (2015) Summary page 5.
- K102704: Easy Cuff, Joan Spiegel, MD (2011) Summary page 5.

## Indications for use
The Accucuff Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.

Source page: https://510kreport.com/device/K182548
Methodology: https://510kreport.com/methodology