Cleared Traditional

SOYALA FULL FACE MASK (K061653) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061653 · Weinmann Gerate Fur Medizin GmbH + Co. KG · Anesthesiology device
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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

Submission Details

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.

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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K061653.
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K061200 · Resmed, Ltd. · Jul 2006