Cleared Traditional

POS T-7000 (K981805) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981805 · Pos Technologies, Inc. · Neurology device
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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.

View all Pos Technologies, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 148d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.