Cleared Traditional

K893780 - OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM

K893780 is an FDA 510(k) clearance for OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA ..., 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 332-day FDA review.

K893780 · Ohmeda Medical · Anesthesiology device
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Apr 1990
Decision
332d
Days
Class 2
Risk

K893780 is an FDA 510(k) clearance for the OHMEDA EXCEL MRI COMPATIBLE 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 19, 1990 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K893780

510(k) Number K893780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date April 19, 1990
Days to Decision 332 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
192d slower than avg
Panel avg: 140d · This submission: 332d
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 K893780.
OHMEDA UNIVERSAL PAC
K901117 · Ohmeda Medical · Sep 1990
NARKOMED 4 ANESTHESIA SYSTEM
K901713 · Draeger Medical, Inc. · Jul 1990
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K901119 · Ohmeda Medical · May 1990
O.R. DATA MANAGER
K900937 · Draeger Medical, Inc. · Apr 1990
NARKOMED 2B ANESTHESIA SYSTEM
K900328 · Draeger Medical, Inc. · Feb 1990
NARKOMED 3 ANESTHESIA SYSTEM
K900329 · Draeger Medical, Inc. · Feb 1990