Cleared Traditional

K973985 - AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)

K973985 is an FDA 510(k) clearance for AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU), manufactured by Datex-Engstrom, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K973985 · Datex-Engstrom, Inc. · Anesthesiology device
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Oct 1998
Decision
375d
Days
Class 2
Risk

K973985 is an FDA 510(k) clearance for the AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU). Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Engstrom, Inc. (Tewksbury, US). The FDA issued a Cleared decision on October 30, 1998 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Datex-Engstrom, Inc. devices

FDA 510(k) Submission Details - K973985

510(k) Number K973985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1997
Decision Date October 30, 1998
Days to Decision 375 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 140d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 119
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K973985.
KION ANESTHESIA SYSTEM
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SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
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NARKOMED 6000 MODEL NUMBER NM6000
K980553 · Draeger Medical, Inc. · Aug 1998
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
K973896 · Ohmeda Medical · Apr 1998
PERIOPERATIVE DATA MANAGEMENT SYSTEM
K973949 · Draeger Medical, Inc. · Feb 1998