# K080256: Pulmodyne CHF Flow Generator System

- Pathway: 510(k) (Traditional)
- Applicant: Pulmodyne
- Decided: May 9, 2008 after 99 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- 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 K801883 (1980). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH, Caradyne, Ltd. (1999) Summary page 1.

## Most influential descendants
- K123957: Pneupac Parapac Plus (2013), 0 descendants of its own
- K122610: Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX Series (2013), 0 descendants of its own

## Indications for use
To provide CPAP to spontaneously breathing adult patients in the hospital and pre-hospital (EMS) environment.

Source page: https://510kreport.com/device/K080256
Methodology: https://510kreport.com/methodology