Cleared Traditional

K935477 - AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD

K935477 is an FDA 510(k) clearance for AS/3(TM) ANESTHESIA MONITOR SYST INTERF..., manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K935477 · Datex Division Instrumentarium Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
259d
Days
Class 2
Risk

K935477 is an FDA 510(k) clearance for the AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on August 1, 1994 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K935477

510(k) Number K935477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date August 01, 1994
Days to Decision 259 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
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 192
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K935477.
COMET CAPNOGRAPH MODULE
K941165 · Spacelabs, Inc. · Oct 1994
PEDI-CAP
K944400 · Nellcor, Inc. · Sep 1994
MINIPACK 911-STC
K925701 · Pace Tech, Inc. · Aug 1994
AS/3 TM NETWORK
K933284 · Datex Division Instrumentarium Corp. · Jul 1994
MASS SPECTROMETRY MONITORING LINES AND CONNECTORS
K942567 · Med-Plastics Intl., Inc. · Jun 1994
END TIDAL CO2 OPTION B
K930524 · Medical Data Electronics · Feb 1994