Cleared Traditional

K901119 - OHMEDA MODULUS CD ANESTHESIA SYSTEM

K901119 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 67-day FDA review.

K901119 · Ohmeda Medical · Anesthesiology device
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May 1990
Decision
67d
Days
Class 2
Risk

K901119 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 May 18, 1990 after a review of 67 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 K901119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date May 18, 1990
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
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 K901119.
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K905635 · Ohmeda Medical · May 1991
OHMEDA UNIVERSAL PAC
K901117 · Ohmeda Medical · Sep 1990
NARKOMED 4 ANESTHESIA SYSTEM
K901713 · Draeger Medical, Inc. · Jul 1990
OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
K893780 · Ohmeda Medical · Apr 1990
O.R. DATA MANAGER
K900937 · Draeger Medical, Inc. · Apr 1990
NARKOMED 2B ANESTHESIA SYSTEM
K900328 · Draeger Medical, Inc. · Feb 1990