# K040202: Salter Labs Cpap High Flow Cannula System

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Mar 4, 2005 after 400 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K953930 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010263: Remstar Plus Cpap System, Respironics, Inc. (2001). Our reading of the summary gave K012263, FDA’s number for Marquette Eagle Monitor Model 4000, Model N3024 (National Custom Ent., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Respironics REMstar CPAP System”.
- K993433: Virtuoso LX Smart Cpap System, Respironics, Inc. (1999) Summary page 1.
- (no number) InnoMed NasalAire™ CPAP Cannula: named in the summary without a submission number

## Indications for use
The Salter Labs High Volume CPAP Cannula System is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing adult patients within a homecare and hospital environment.

Source page: https://510kreport.com/device/K040202
Methodology: https://510kreport.com/methodology