Cleared Traditional

K894309 - OHMEDA MODULUS CD ANESTHESIA SYSTEM

K894309 is the FDA 510(k) clearance for OHMEDA MODULUS CD ANESTHESIA SYSTEM by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894309 · Ohmeda Medical · Anesthesiology device
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Oct 1989
Decision
84d
Days
Class 2
Risk

K894309 is an FDA 510(k) clearance for the OHMEDA MODULUS CD 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 October 6, 1989 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohmeda Medical devices

Submission Details

510(k) Number K894309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date October 06, 1989
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
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 K894309.
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
CAVENDISH 460/680 ANESTHESIA MACHINE
K884802 · Dentsply Intl. · Aug 1989
CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
K884991 · Datex Division Instrumentarium Corp. · Jun 1989
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
K890410 · Ohmeda Medical · Apr 1989