# K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH

- Pathway: 510(k) (Traditional)
- Applicant: Caradyne, Ltd.
- Decided: Mar 9, 1999 after 252 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: 1 generation back to K801883 (1980). 4 ancestors in all.
14 later devices descend from it; 4 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811393: Downs Cap Flow Generator, Vital Signs, Inc. (1981) Summary page 1.
- K831503: Downs Adjustable Flow Generator, Vital Signs, Inc. (1983) Summary page 1.
- K801883: Peep Face Mask, Vital Signs, Inc. (1980) Summary page 1.
- K871851: Ribbed Cushion Mask, Engineered Medical Systems (1987) Summary page 1.

## Most influential descendants
- K080692: Macs Cpap System (2008), 7 descendants of its own
- K092085: Ispira Resuscitation Unit (2009), 4 descendants of its own
- K013884: Boussignac C.P.a.P. Device (2003), 4 descendants of its own
- K102649: Neopop Infant Resuscitator with Flow Meter (2011), 2 descendants of its own
- K080256: Pulmodyne CHF Flow Generator System (2008), 2 descendants of its own

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

Source page: https://510kreport.com/device/K982283
Methodology: https://510kreport.com/methodology