# K072993: Reusable Headrest with Nasal Seal

- Pathway: 510(k) (Abbreviated)
- Applicant: Aeiomed, Inc.
- Decided: Feb 8, 2008 after 108 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: 4 generations back to K900164 (1990). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042130: Aura Cpap Patient Interface, Aeiomed, Inc. (2004) Summary page 1.
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.

## Most influential descendants
- K090804: Nasal Aire II Pediatric, Model 5 Sizes, Model TBD (2009), 0 descendants of its own

## Indications for use
The Headrest® with Nasal Seal is a reusable accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.

Source page: https://510kreport.com/device/K072993
Methodology: https://510kreport.com/methodology