Cleared Traditional

K844849 - OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA

K844849 is an FDA 510(k) clearance for OHMEDA MDM ELECTRONIC-GAS MACHINE FOR A..., manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K844849 · Ohmeda Medical · Anesthesiology device
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May 1985
Decision
153d
Days
Class 2
Risk

K844849 is an FDA 510(k) clearance for the OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on May 15, 1985 after a review of 153 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K844849

510(k) Number K844849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1984
Decision Date May 15, 1985
Days to Decision 153 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 140d · This submission: 153d
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 K844849.
NARKOMED 3 ANESTHESIA SYSTEM
K853435 · Draeger Medical, Inc. · Jan 1986
ARI STANDARD ANESTHESIA RECORD
K854213 · Agilent Technologies, Inc. · Dec 1985
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · Ohmeda Medical · Jul 1985
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
FOREGGER DOME VALVES
K844421 · Puritan Bennett Corp. · Jan 1985
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · Ohmeda Medical · Oct 1984