Cleared Traditional

K832113 - NORMAC ANESTHETIC AGENT MONITOR

K832113 is an FDA 510(k) clearance for NORMAC ANESTHETIC AGENT MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K832113 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Sep 1983
Decision
74d
Days
Class 2
Risk

K832113 is an FDA 510(k) clearance for the NORMAC ANESTHETIC AGENT MONITOR. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki 10 Finland, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 74 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K832113

510(k) Number K832113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date September 12, 1983
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K832113.
NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR
K896629 · Nellcor, Inc. · Feb 1990
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · Hewlett-Packard Co. · Jan 1990
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · Draeger Medical, Inc. · Oct 1987
SARA
K810585 · Allied Healthcare Products, Inc. · Mar 1981
ENGSTROM EMMA ANESTHETIC GAS MONITOR
K802614 · Lkb Instruments, Inc. · Jan 1981