# K102515: NP15

- Pathway: 510(k) (Traditional)
- Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Decided: Mar 11, 2011 after 190 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 K945938 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082558: Comfortlite Nasal Mask, Respironics, Inc. (2009) Summary page 1.

## Indications for use
The NP 15 is intended for *adult patients (> 30 kg) prescribed continuous positive airway pressure (CRAP) or bi-level therapy, *multiple-patient use in a hospital or clinic environment after high-level disinfection, *single-patient use in a home environment.

Source page: https://510kreport.com/device/K102515
Methodology: https://510kreport.com/methodology