Cleared Traditional

K965041 - OHMEDA APAC (ADVANCED PORTABLE ANESTHES...

K965041 is the FDA 510(k) clearance for OHMEDA APAC (ADVANCED PORTABLE ANESTHES... by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K965041 · Ohmeda Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K965041.
NARKOMED ULTRASONIC FLOW SENSOR
K974193 · Draeger Medical, Inc. · Jan 1998
NARKOMED MRI ANESTHESIA SYSTEM
K972848 · Draeger Medical, Inc. · Oct 1997
NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · Draeger Medical, Inc. · Sep 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