# K061057: Breas Isleep 20+

- Pathway: 510(k) (Special)
- Applicant: Breas Medical AB
- Decided: Jun 23, 2006 after 67 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: 6 generations back to K903764 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030985: Breas PV 10I Cpap System, Model PV 10I, Vital Signs, Inc. (2003) Summary page 1.

## Indications for use
The Breas iSleep 20+ System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

Source page: https://510kreport.com/device/K061057
Methodology: https://510kreport.com/methodology