Cleared Traditional

K973896 - OHMEDA EXCEL 3000 ANESTHESIA SYSTEM

K973896 is the FDA 510(k) clearance for OHMEDA EXCEL 3000 ANESTHESIA SYSTEM by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K973896 · Ohmeda Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
189d
Days
Class 2
Risk

K973896 is an FDA 510(k) clearance for the OHMEDA EXCEL 3000 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 April 21, 1998 after a review of 189 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 K973896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1997
Decision Date April 21, 1998
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
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 K973896.
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K983635 · Draeger Medical, Inc. · Jan 1999
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
K981530 · Spacelabs Medical, Inc. · Nov 1998
NARKOMED 6000 MODEL NUMBER NM6000
K980553 · Draeger Medical, Inc. · Aug 1998
PERIOPERATIVE DATA MANAGEMENT SYSTEM
K973949 · Draeger Medical, Inc. · Feb 1998
NARKOMED ULTRASONIC FLOW SENSOR
K974193 · Draeger Medical, Inc. · Jan 1998
NARKOMED MRI ANESTHESIA SYSTEM
K972848 · Draeger Medical, Inc. · Oct 1997