Cleared Traditional

K061653 - SOYALA FULL FACE MASK

K061653 is an FDA 510(k) clearance for SOYALA FULL FACE MASK, manufactured by Weinmann Gerate Fur Medizin GmbH + Co. KG. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K061653 · Weinmann Gerate Fur Medizin GmbH + Co. KG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
149d
Days
Class 2
Risk

K061653 is an FDA 510(k) clearance for the SOYALA FULL FACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Weinmann Gerate Fur Medizin GmbH + Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 9, 2006 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Weinmann Gerate Fur Medizin GmbH + Co. KG devices

FDA 510(k) Submission Details - K061653

510(k) Number K061653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2006
Decision Date November 09, 2006
Days to Decision 149 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 140d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K061653.
MIRAGE LIBERTY FULL FACE MASK
K063011 · Resmed, Ltd. · Feb 2007
MIRAGE QUATTRO FULL FACE MASK
K063122 · Resmed, Ltd. · Feb 2007
OPUS HC482 DIRECT NASAL MASK
K063036 · Fisher &Paykel Healthcare , Ltd. · Dec 2006
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