Cleared Traditional

K072136 - ULTRASONIC NEBULISER MODEL 2010

K072136 is an FDA 510(k) clearance for ULTRASONIC NEBULISER MODEL 2010, manufactured by Wilfred Kromker GmbH. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K072136 · Wilfred Kromker GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
348d
Days
Class 2
Risk

K072136 is an FDA 510(k) clearance for the ULTRASONIC NEBULISER MODEL 2010. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Wilfred Kromker GmbH (Egale, US). The FDA issued a Cleared decision on July 15, 2008 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K072136

510(k) Number K072136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date July 15, 2008
Days to Decision 348 days
Submission Type Traditional
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
208d slower than avg
Panel avg: 140d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K072136.
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
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NEB-U-MASK SYSTEM, MODELS 1895, 1896
K080230 · Teleflexmedical, Inc. · Jun 2008
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
K072163 · 3A Health Care S.R.L. · Mar 2008