Cleared Traditional

K012691 - MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES

K012691 is an FDA 510(k) clearance for MONSOON 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 493-day FDA review.

K012691 · Acutronic Medical Systems AG · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
493d
Days
Class 2
Risk

K012691 is an FDA 510(k) clearance for the MONSOON 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 December 20, 2002 after a review of 493 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K012691

510(k) Number K012691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date December 20, 2002
Days to Decision 493 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
353d slower than avg
Panel avg: 140d · This submission: 493d
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 488
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K012691.
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
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K023289 · Drager Medizintechnik GmbH · Jan 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
INSPIRATION VENTILATOR SYSTEM
K021112 · eVent Medical, Ltd. · Nov 2002
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
K023350 · Respironics California, Inc. · Nov 2002
K012691 · MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
Download PDF FDA Summary Acutronic Medical Sys…