Cleared Traditional

K981845 - HAWK ANAESTHESIA INDUCTION UNIT

K981845 is an FDA 510(k) clearance for HAWK ANAESTHESIA INDUCTION UNIT, manufactured by Medical Industrial Equipment. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K981845 · Medical Industrial Equipment · Anesthesiology device
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Nov 1998
Decision
161d
Days
Class 2
Risk

K981845 is an FDA 510(k) clearance for the HAWK ANAESTHESIA INDUCTION UNIT. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Medical Industrial Equipment (Exeter, Devon, GB). The FDA issued a Cleared decision on November 3, 1998 after a review of 161 days - an extended review cycle.

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. 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 Medical Industrial Equipment devices

FDA 510(k) Submission Details - K981845

510(k) Number K981845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1998
Decision Date November 03, 1998
Days to Decision 161 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
21d slower than avg
Panel avg: 140d · This submission: 161d
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 133
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K981845.
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
K982137 · Blease Medical Equipment , Ltd. · Apr 1999
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K983635 · Draeger Medical, Inc. · Jan 1999
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
K981530 · Spacelabs Medical, Inc. · Nov 1998
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
K973985 · Datex-Engstrom, Inc. · Oct 1998
NARKOMED 6000 MODEL NUMBER NM6000
K980553 · Draeger Medical, Inc. · Aug 1998
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
K973896 · Ohmeda Medical · Apr 1998