Cleared Special

K060657 - ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060657 · Breas Medical AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
158d
Days
Class 2
Risk

K060657 is an FDA 510(k) clearance for the ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on August 18, 2006 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Breas Medical AB devices

Submission Details

510(k) Number K060657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2006
Decision Date August 18, 2006
Days to Decision 158 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 139d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 456
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K060657.
F6S Full Face Mask (F6S)
K253166 · BMC Medical Co., Ltd. · Apr 2026
MySleepDash
K252338 · Somnetics International, Inc. (Dba Transcend Inc) · Apr 2026
Sleepnet Arie Full Face Vented Mask
K251847 · Sleepnet Corporation · Jan 2026
DeltaWave Nasal Pillow System
K253939 · RemSleep Holdings, Inc. · Jan 2026
SleepRes PAP System
K251770 · Sleepres, Inc. · Dec 2025
Personalized Therapy Comfort Settings (PTCS)
K251657 · ResMed Corp · Dec 2025