Cleared Traditional

K893780 - OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA ...

K893780 is the FDA 510(k) clearance for OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA ... by Ohmeda Medical. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 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