# K251770: SleepRes PAP System

- Pathway: 510(k) (Traditional)
- Applicant: Sleepres, Inc.
- Decided: Dec 15, 2025 after 188 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: 13 generations back to K953930 (1996). 36 ancestors in all.
No later device cites it as a predicate yet.
5 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200480: DreamStation 2 System, DreamStation 2 Advanced System, Respironics, Inc. (2020) Summary page 5.

## Indications for use
The SleepRes PAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. (30 kg.). The SleepRes PAP system is intended for home, hospital / institutional and sleep center settings.

Source page: https://510kreport.com/device/K251770
Methodology: https://510kreport.com/methodology