Cleared Traditional

K821910 - ANESTHESIA & BRAIN MONITOR

K821910 is an FDA 510(k) clearance for ANESTHESIA & BRAIN MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K821910 · Datex Division Instrumentarium Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
71d
Days
Class 2
Risk

K821910 is an FDA 510(k) clearance for the ANESTHESIA & BRAIN MONITOR. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Walker, US). The FDA issued a Cleared decision on September 7, 1982 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - the FDA neurology 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 - K821910

510(k) Number K821910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date September 07, 1982
Days to Decision 71 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 148d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Neurology devices follow this clearance model.

Regulatory Peers - IKN Electromyograph, Diagnostic

All 24
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K821910.
NICOLET EMG SATELLITE
K830702 · Nicolet Biomedical Instruments · Jul 1983
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624 · Del Mar Avionics · Oct 1982
TECA #TE 8
K812715 · Teca, Inc. · Oct 1981
TECA MODEL-10 ELECTROMYOGRAPH
K802637 · Teca, Inc. · Nov 1980
CADWELL 7200
K800648 · Cadwell Laboratories, Inc. · Apr 1980