Cleared Traditional

K950101 - RAMS (RANDOM ACCESS MASS SPECTROMETER) ...

K950101 is the FDA 510(k) clearance for RAMS (RANDOM ACCESS MASS SPECTROMETER) ... by Marquette Electronics, Inc.. It is a Class 2 Anesthesiology device (product code CBS) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K950101 · Marquette Electronics, Inc. · Anesthesiology device
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Mar 1995
Decision
69d
Days
Class 2
Risk

K950101 is an FDA 510(k) clearance for the RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - 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 Marquette Electronics, Inc. devices

Submission Details

510(k) Number K950101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1995
Decision Date March 21, 1995
Days to Decision 69 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
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 - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 8
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K950101.
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K873194 · Draeger Medical, Inc. · Oct 1987