Cleared Traditional

K905635 - OHMEDA MODULUS CD ANESTHESIA SYSTEM

K905635 is an FDA 510(k) clearance for OHMEDA MODULUS CD ANESTHESIA SYSTEM, 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 137-day FDA review.

K905635 · Ohmeda Medical · Anesthesiology device
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May 1991
Decision
137d
Days
Class 2
Risk

K905635 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 3, 1991 after a review of 137 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K905635

510(k) Number K905635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1990
Decision Date May 03, 1991
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
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 K905635.
MAC/IV SEDATION KIT
K935546 · Vital Signs, Inc. · Jun 1994
NARKOMED 2C ANESTHESIA SYSTEM
K930351 · Draeger Medical, Inc. · Jun 1993
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K921742 · Ohmeda Medical · May 1993
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