# K191858: Pylant Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Kal-Med, LLC
- Decided: Feb 24, 2020 after 228 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: 1 generation back to K833327 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833327: Respironics PR Valve, Respironics, Inc. (1983) Summary page 4.

## Indications for use
To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.

Source page: https://510kreport.com/device/K191858
Methodology: https://510kreport.com/methodology