Cleared Traditional

WEINMANNCOMPACT, MODEL WM 27380 (K072009) - FDA 510(k) Clearance

Also marketed or referenced as:
WEINMANNCLICK2, MODEL WM 27340

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

K072009 · Weinmann Gerate Fur Medizin GmbH + Co. KG · Anesthesiology device
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Dec 2007
Decision
144d
Days
Class 2
Risk

K072009 is an FDA 510(k) clearance for the WEINMANNCOMPACT, MODEL WM 27380. 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 December 14, 2007 after a review of 144 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 K072009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date December 14, 2007
Days to Decision 144 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
4d slower than avg
Panel avg: 140d · This submission: 144d
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)

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