Cleared Traditional

K894889 - TECA NEUROMAPPER 386

K894889 is an FDA 510(k) clearance for TECA NEUROMAPPER 386, manufactured by Teca, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K894889 · Teca, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
143d
Days
Class 2
Risk

K894889 is an FDA 510(k) clearance for the TECA NEUROMAPPER 386. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teca, Inc. devices

FDA 510(k) Submission Details - K894889

510(k) Number K894889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date December 22, 1989
Days to Decision 143 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
5d faster than avg
Panel avg: 148d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 17
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K894889.
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K000892 · Datex-Ohmeda, Inc. · Jun 2000
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc. · Jun 1999
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · Biosound, Inc. · Feb 1994
TECA NEUROMAPPER 1620, BRAIN MAPPER
K894088 · Teca, Inc. · Nov 1989
SLEEP STAGER
K850541 · Oxford Medilog, Inc. · Aug 1985
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K843808 · Datex Division Instrumentarium Corp. · Nov 1984