# K811393: Downs Cap Flow Generator

- Pathway: 510(k) (Traditional)
- Applicant: Vital Signs, Inc.
- Decided: Jun 9, 1981 after 22 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH (1999), 14 descendants of its own
- 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

Source page: https://510kreport.com/device/K811393
Methodology: https://510kreport.com/methodology