Cleared Traditional

K900744 - AMS 3000 PORTABLE JET VENTILATOR

K900744 is an FDA 510(k) clearance for AMS 3000 PORTABLE JET VENTILATOR, 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 437-day FDA review.

K900744 · Acutronic Medical Systems AG · Anesthesiology device
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Apr 1991
Decision
437d
Days
Class 2
Risk

K900744 is an FDA 510(k) clearance for the AMS 3000 PORTABLE JET VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Acutronic Medical Systems AG (Jona-Rapper Swril, CH). The FDA issued a Cleared decision on April 29, 1991 after a review of 437 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.

View all Acutronic Medical Systems AG devices

FDA 510(k) Submission Details - K900744

510(k) Number K900744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date April 29, 1991
Days to Decision 437 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 140d · This submission: 437d
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 K900744.
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991
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K903089 · Drager, Inc. · Jun 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · Mallinckrodt Medical · Mar 1991
ADULT STAR, MODIFICATION
K905272 · Infrasonics Corp. · Jan 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991