Cleared Special

K073673 - SOYALA FULL FACE MASK GEL VENTED

K073673 is an FDA 510(k) clearance for SOYALA FULL FACE MASK GEL VENTED, manufactured by Weinmann Gerate Fur Medizin GmbH + Co. KG. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 92-day FDA review.

K073673 · Weinmann Gerate Fur Medizin GmbH + Co. KG · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
92d
Days
Class 2
Risk

K073673 is an FDA 510(k) clearance for the SOYALA FULL FACE MASK GEL VENTED. 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 March 28, 2008 after a review of 92 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. 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.

FDA 510(k) Submission Details - K073673

510(k) Number K073673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2007
Decision Date March 28, 2008
Days to Decision 92 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 140d · This submission: 92d
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 458
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K073673.
COMFORTGEL FULL FACE MASK
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S8 ESCAPE II
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VPAP ST
K080131 · Resmed, Ltd. · Apr 2008
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K073638 · Resmed, Ltd. · Mar 2008
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K072993 · Aeiomed, Inc. · Feb 2008
HRI 6500, 6600 AND 6700 SERIES V2MASKS
K071149 · Hans Rudolph, Inc. · Feb 2008