Cleared Traditional

K965041 - OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM

K965041 is an FDA 510(k) clearance for OHMEDA APAC (ADVANCED PORTABLE ANESTHES..., 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 182-day FDA review.

K965041 · Ohmeda Medical · Anesthesiology device
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Jun 1997
Decision
182d
Days
Class 2
Risk

K965041 is an FDA 510(k) clearance for the OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) 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 June 17, 1997 after a review of 182 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 - K965041

510(k) Number K965041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date June 17, 1997
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 140d · This submission: 182d
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 K965041.
HP ORVUE INTRA-OP (M2510A)
K965160 · Hewlett-Packard GmbH · Sep 1997
NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · Draeger Medical, Inc. · Sep 1997
ANODYNE CC
K963481 · Heyer America, Inc. · Aug 1997
NARKOMED GS ANESTHESIA SYSTEM
K963994 · Draeger Medical, Inc. · Mar 1997
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
K946127 · Ohmeda Medical · Oct 1996
PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
K945463 · Draeger Medical, Inc. · Feb 1995