Cleared Traditional

BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE (K982137) - FDA 510(k) Clearance

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

K982137 · Blease Medical Equipment , Ltd. · Anesthesiology device
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Apr 1999
Decision
296d
Days
Class 2
Risk

K982137 is an FDA 510(k) clearance for the BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Blease Medical Equipment , Ltd. (Orlando, US). The FDA issued a Cleared decision on April 9, 1999 after a review of 296 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 Blease Medical Equipment , Ltd. devices

Submission Details

510(k) Number K982137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date April 09, 1999
Days to Decision 296 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 140d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K982137.
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KION ANESTHESIA SYSTEM
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K973896 · Ohmeda Medical · Apr 1998
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
K965041 · Ohmeda Medical · Jun 1997
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
K946127 · Ohmeda Medical · Oct 1996