Cleared Traditional

K903991 - PCM ANESTHESIA

K903991 is the FDA 510(k) clearance for PCM ANESTHESIA by Siemens Life Support Systems. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K903991 · Siemens Life Support Systems · Anesthesiology device
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Feb 1991
Decision
180d
Days
Class 2
Risk

K903991 is an FDA 510(k) clearance for the PCM ANESTHESIA. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Siemens Life Support Systems (Schaumburg, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 180 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 Siemens Life Support Systems devices

Submission Details

510(k) Number K903991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date February 25, 1991
Days to Decision 180 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 140d · This submission: 180d
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 67
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K903991.
NARKOMED 2C ANESTHESIA SYSTEM
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OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K921742 · Ohmeda Medical · May 1993
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 MODULUS CD ANESTHESIA SYSTEM
K901119 · Ohmeda Medical · May 1990