Cleared Special

K060657 - ISLEEP BY BREAS

K060657 is an FDA 510(k) clearance for ISLEEP BY BREAS, manufactured by Breas Medical AB. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 158-day FDA review.

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

FDA 510(k) Submission Details - K060657

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
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

BZD Device Classification - Class 2, Special Controls

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 286
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K060657.
VPAP MALIBU WITH H2I
K062291 · Resmed, Ltd. · Sep 2006
INVACARE'S TWILIGHT II NASAL MASKS
K061874 · Invacare Corp. · Sep 2006
FLEXIFIT HC432 FULL FACE MASK
K061236 · Fisher &Paykel Healthcare , Ltd. · Aug 2006
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
K061200 · Resmed, Ltd. · Jul 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · Respironics, Inc. · Jun 2006
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
K060273 · Sleepnet Corporation · May 2006