Cleared Traditional

K901117 - OHMEDA UNIVERSAL PAC

K901117 is the FDA 510(k) clearance for OHMEDA UNIVERSAL PAC by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K901117 · Ohmeda Medical · Anesthesiology device
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Sep 1990
Decision
183d
Days
Class 2
Risk

K901117 is an FDA 510(k) clearance for the OHMEDA UNIVERSAL PAC. 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 September 7, 1990 after a review of 183 days - an extended review 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: 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

Submission Details

510(k) Number K901117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1990
Decision Date September 07, 1990
Days to Decision 183 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
43d slower than avg
Panel avg: 140d · This submission: 183d
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 K901117.
NARKOMED 2C ANESTHESIA SYSTEM
K930351 · Draeger Medical, Inc. · Jun 1993
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K921742 · Ohmeda Medical · May 1993
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K905635 · Ohmeda Medical · May 1991
NARKOMED 4 ANESTHESIA SYSTEM
K901713 · Draeger Medical, Inc. · Jul 1990
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K901119 · Ohmeda Medical · May 1990
OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
K893780 · Ohmeda Medical · Apr 1990