Cleared Traditional

K981805 - POS T-7000

K981805 is an FDA 510(k) clearance for POS T-7000, manufactured by Pos Technologies, Inc.. The device is a Class 2 Neurology device with product code HCS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K981805 · Pos Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
78d
Days
Class 2
Risk

K981805 is an FDA 510(k) clearance for the POS T-7000. Classified as Device, Temperature Measurement, Direct Contact, Powered (product code HCS), Class II - Special Controls.

Submitted by Pos Technologies, Inc. (Nashua, US). The FDA issued a Cleared decision on August 7, 1998 after a review of 78 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 - K981805

510(k) Number K981805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date August 07, 1998
Days to Decision 78 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 149d · This submission: 78d
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 K981805.
TYTRON C-3000
K974208 · Titronics Research & Development Co. · Feb 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
K981805 · POS T-7000
Download PDF Pos Technologies, Inc.