# K080692: Macs Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Airon Corporation
- Decided: Jun 20, 2008 after 101 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862830 (1986). 11 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024344: Pneuton Ventilator, Airon Corporation (2003) Summary page 1.
- K043085: Modification to: Pneuton Ventilator, Airon Corporation (2004) Summary page 1.
- K021520: Emt-Cpap, Emergency Medical Techology (2002) Summary page 1.
- 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
- K092085: Ispira Resuscitation Unit (2009), 4 descendants of its own
- K102649: Neopop Infant Resuscitator with Flow Meter (2011), 2 descendants of its own
- K110119: Pressure Manometer (2011), 1 descendant of its own
- K093862: Carevent Handheld Cpap System (2010), 1 descendant of its own
- K142096: T-Piece Resuscitator (2014), 0 descendants of its own

## Indications for use
To provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.

Source page: https://510kreport.com/device/K080692
Methodology: https://510kreport.com/methodology