Cleared Traditional

K974208 - TYTRON C-3000

K974208 is an FDA 510(k) clearance for TYTRON C-3000, manufactured by Titronics Research & Development Co.. The device is a Class 2 Neurology device with product code HCS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K974208 · Titronics Research & Development Co. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
85d
Days
Class 2
Risk

K974208 is an FDA 510(k) clearance for the TYTRON C-3000. Classified as Device, Temperature Measurement, Direct Contact, Powered (product code HCS), Class II - Special Controls.

Submitted by Titronics Research & Development Co. (Oxford, US). The FDA issued a Cleared decision on February 3, 1998 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1570 - 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.

FDA 510(k) Submission Details - K974208

510(k) Number K974208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date February 03, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 149d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCS Device Classification - Class 2, Special Controls

Product Code HCS Device, Temperature Measurement, Direct Contact, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1570
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 - HCS Device, Temperature Measurement, Direct Contact, Powered

All 7
Devices cleared under the same product code (HCS) and FDA review panel - the closest regulatory comparables to K974208.
POS T-7000
K981805 · Pos Technologies, Inc. · Aug 1998
NEUROREADER
K950986 · Artronics · Nov 1995
THERMALGRAPHIC ANALYSER
K894772 · Medtech Instruments · Oct 1989
T-METER
K840487 · K.J. Electronics · Mar 1984
TRENDO-SCOPE
K831995 · Gabriel Ent. · Aug 1983
GABRIEL DIGITREND
K822795 · Gabriel Ent. · Oct 1982
K974208 · TYTRON C-3000
Download PDF FDA Summary Titronics Research & …