Cleared Special

K081014 - SOYALA GEL VENTED

K081014 is an FDA 510(k) clearance for SOYALA 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 30-day FDA review.

K081014 · Weinmann Gerate Fur Medizin GmbH + Co. KG · Anesthesiology device
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May 2008
Decision
30d
Days
Class 2
Risk

K081014 is an FDA 510(k) clearance for the SOYALA 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 May 9, 2008 after a review of 30 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

FDA 510(k) Submission Details - K081014

510(k) Number K081014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2008
Decision Date May 09, 2008
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 307
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