Cleared Traditional

UNIVERSAL JET VENTILATOR MODEL AMS-1000 (K863155) - FDA 510(k) Clearance

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

K863155 · Acutronic Medical Systems AG · Anesthesiology device
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Sep 1987
Decision
409d
Days
Class 2
Risk

K863155 is an FDA 510(k) clearance for the UNIVERSAL JET VENTILATOR MODEL AMS-1000. 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 September 28, 1987 after a review of 409 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

Submission Details

510(k) Number K863155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date September 28, 1987
Days to Decision 409 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 140d · This submission: 409d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 120
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K863155.
PRESSURE LIMIT CONTROL
K874415 · Draeger Medical, Inc. · Jan 1988
ASCENDING VENTILATOR BELLOWS
K874371 · Draeger Medical, Inc. · Dec 1987
PEDIATRIC BELLOWS
K873549 · Draeger Medical, Inc. · Oct 1987
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · Puritan Bennett Corp. · Mar 1987
PEDIATRIC BELLOWS
K864431 · Draeger Medical, Inc. · Jan 1987