Cleared Traditional

K850648 - OHMEDA PAC PORTABLE ANESTHESIA SYSTEM

K850648 is the FDA 510(k) clearance for OHMEDA PAC PORTABLE ANESTHESIA SYSTEM by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K850648 · Ohmeda Medical · Anesthesiology device
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Jul 1985
Decision
132d
Days
Class 2
Risk

K850648 is an FDA 510(k) clearance for the OHMEDA PAC PORTABLE ANESTHESIA SYSTEM. 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 July 1, 1985 after a review of 132 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K850648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date July 01, 1985
Days to Decision 132 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
8d faster than avg
Panel avg: 140d · This submission: 132d
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 101
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K850648.
MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K862831 · Ohmeda Medical · Aug 1986
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K861170 · Draeger Medical, Inc. · Apr 1986
NARKOMED 3 ANESTHESIA SYSTEM
K853435 · Draeger Medical, Inc. · Jan 1986
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · Ohmeda Medical · May 1985
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
FOREGGER DOME VALVES
K844421 · Puritan Bennett Corp. · Jan 1985