# K060657: Isleep by Breas, Models Isleep 10, Isleep 20.

- Pathway: 510(k) (Special)
- Applicant: Breas Medical AB
- Decided: Aug 18, 2006 after 158 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0001553: Breas PV100. Number could not be read

## Indications for use
The iSleep 10 and 20 are intended for non-invasive use. The iSleep 10 and 20 shall only be used by patients with spontaneous breathing. The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg). The iSleep 10 and 20 are intended to be operated by trained users and qualified personnel. The iSleep 10 and 20 can be used in clinical settings (e.g., hospitals, sleep laboratories, subacute care institutions) and home environments. They must always be prescribed by a licensed physician.

Source page: https://510kreport.com/device/K060657
Methodology: https://510kreport.com/methodology