# K092733: PYTON

- Pathway: 510(k) (Traditional)
- Applicant: Arm Medical Devices, Inc.
- Decided: Feb 26, 2010 after 175 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: 2 generations back to K912723 (1991). 5 ancestors in all.
27 later devices descend from it; 5 cite it directly.
8 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902114: Cuff-Mate 2 Endotracheal Cuff Inflator & Monitor, Diemolding Corp. (1990) Summary page 1.
- K912723: Posey Cufflator, Posey Co. (1991) Summary page 1.
- K951046: Rusch Endotest Cuff Pressure Monitor, Rusch Intl. (1995) Summary page 1.
- K791045: Model GV-10 Lanz Pressure-Valve, Extracorporeal Medical Specialities, Inc. (1979) Summary page 4.
- K081805: Cuffalert, Sunmed (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K083327: Syngocirculation Dynamicpet, Version 1.0, Siemens Medical Solutions USA, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K131774: Hamilton-G5 (2013), 10 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K150893: IntelliCuff (2016), 5 descendants of its own
- K123637: Hamilton-C3 (2012), 4 descendants of its own

## Indications for use
To measure, and regulate intra-cuff pressures of endotracheal supraglottic airways or tracheostomy tubes. The PYTON is intended for use on patients who are intubated. The PYTON is to be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics where a patient may be intubated.

Source page: https://510kreport.com/device/K092733
Methodology: https://510kreport.com/methodology