Cleared Traditional

K012693 - MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES

K012693 is an FDA 510(k) clearance for MISTRAL CRITICAL CARE JET VENTILATOR AN..., manufactured by Acutronic Medical Systems AG. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K012693 · Acutronic Medical Systems AG · Anesthesiology device
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Aug 2002
Decision
352d
Days
Class 2
Risk

K012693 is an FDA 510(k) clearance for the MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Acutronic Medical Systems AG (Tucson, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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.

View all Acutronic Medical Systems AG devices

FDA 510(k) Submission Details - K012693

510(k) Number K012693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date August 01, 2002
Days to Decision 352 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
212d slower than avg
Panel avg: 140d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 357
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K012693.
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
AVEA
K013642 · Bird Products Corp. · May 2002
BIRD TBIRD VELA VENTILATOR
K020746 · Bird Products Corp. · Apr 2002
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · Siemens Elema AB · Dec 2001