Cleared Special

K112167 - SOYALA SILKGEL FULL FACE MASK

K112167 is an FDA 510(k) clearance for SOYALA SILKGEL 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 Special 510(k) pathway after a 111-day FDA review.

K112167 · 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
Nov 2011
Decision
111d
Days
Class 2
Risk

K112167 is an FDA 510(k) clearance for the SOYALA SILKGEL 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 16, 2011 after a review of 111 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 - K112167

510(k) Number K112167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2011
Decision Date November 16, 2011
Days to Decision 111 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
29d faster than avg
Panel avg: 140d · This submission: 111d
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.

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All 458
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