# K100343: Pap-Cap

- Pathway: 510(k) (Traditional)
- Applicant: Pur-Sleep, Inc.
- Decided: Apr 23, 2010 after 77 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: 5 generations back to K953930 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042294: Slumbergear (TM), Model Multiple (004, 005, 005, 007), Suiter Enterprises, Inc. (2004) Summary page 1.

## Indications for use
PAP-CapTM headgear is an accessory intended for patients using CPAP or bi-level devices in hospitals, institutions, sleep labs, and /or home environments. The headgear is single patient, multi-use.

Source page: https://510kreport.com/device/K100343
Methodology: https://510kreport.com/methodology