Cleared Traditional

K890410 - REVISED OHMEDA MODULUS II ANESTHESIA GA...

K890410 is the FDA 510(k) clearance for REVISED OHMEDA MODULUS II ANESTHESIA GA... by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K890410 · Ohmeda Medical · Anesthesiology device
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Apr 1989
Decision
78d
Days
Class 2
Risk

K890410 is an FDA 510(k) clearance for the REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE. 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 12, 1989 after a review of 78 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 K890410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date April 12, 1989
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 K890410.
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K894309 · Ohmeda Medical · Oct 1989
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 PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K882489 · Ohmeda Medical · Jul 1988
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
K875350 · Ohmeda Medical · Mar 1988
NARKOMED 2B ANESTHESIA SYSTEM
K864447 · Draeger Medical, Inc. · Jan 1987