Cleared Traditional

K883865 - EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010

K883865 is an FDA 510(k) clearance for EXTERNAL JET SYNCHRONIZER, 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 268-day FDA review.

K883865 · Acutronic Medical Systems AG · Anesthesiology device
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Jun 1989
Decision
268d
Days
Class 2
Risk

K883865 is an FDA 510(k) clearance for the EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010. 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 June 8, 1989 after a review of 268 days - an extended review cycle.

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. Standard predicate reliance. 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 - K883865

510(k) Number K883865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date June 08, 1989
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 140d · This submission: 268d
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 K883865.
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
NEWPORT VENTILATOR MODEL E150
K883809 · Newport Medical Instruments, Inc. · Jun 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989
STAR SYNC
K884521 · Infrasonics Corp. · Jun 1989
OHMEDA 7800 ANESTHESIA VENTILATOR
K883159 · Ohmeda Medical · Jun 1989
BEAR EVC-100 CONTROLLER
K882764 · Bear Medical Systems, Inc. · Sep 1988