# K122350: Tap Pap Nasal Pillow Mask

- Pathway: 510(k) (Traditional)
- Applicant: Airway Management, Inc.
- Decided: Nov 1, 2012 after 90 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: 1 generation back to K992384 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992384: Cpap/Pro Cpap Interface, Stevenson Industries, Inc. (1999) Summary page 2.

## Indications for use
The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66 lb/30 kg) use in the home, hospital or other clinical setting.

Source page: https://510kreport.com/device/K122350
Methodology: https://510kreport.com/methodology