Cleared Traditional

K864589 - TRI-SERVICE OMV VAPORIZER

K864589 is the FDA 510(k) clearance for TRI-SERVICE OMV VAPORIZER by Bear Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K864589 · Bear Medical Systems, Inc. · Anesthesiology device
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Jun 1987
Decision
196d
Days
Class 2
Risk

K864589 is an FDA 510(k) clearance for the TRI-SERVICE OMV VAPORIZER. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 196 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 Bear Medical Systems, Inc. devices

Submission Details

510(k) Number K864589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date June 05, 1987
Days to Decision 196 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 140d · This submission: 196d
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 67
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K864589.
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
K890410 · Ohmeda Medical · Apr 1989
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K882489 · Ohmeda Medical · Jul 1988
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
K875350 · Ohmeda Medical · Mar 1988
NARKOMED 2B ANESTHESIA SYSTEM
K864447 · Draeger Medical, Inc. · Jan 1987
ANESTHESIA RECORDER
K864806 · Draeger Medical, Inc. · Jan 1987
OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
K863207 · Ohmeda Medical · Oct 1986