# K063476: Breas Isleep 20I

- Pathway: 510(k) (Special)
- Applicant: Breas Medical AB
- Decided: Jan 22, 2007 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.
12 later devices descend from it; 2 cite it directly.
0 of 27 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.

## Most influential descendants
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own
- K090398: Provent Professional Sleep Apnea Therapy (2009), 3 descendants of its own
- K130538: Winx Sleep Therapy System (2013), 2 descendants of its own

## Indications for use
The Breas iSleep 20i 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/K063476
Methodology: https://510kreport.com/methodology