Cleared Traditional

K821631 - PINCH GAUGE

K821631 is an FDA 510(k) clearance for PINCH GAUGE, manufactured by Fred Sammons, Inc.. The device is a Class 1 Neurology device with product code HRW cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K821631 · Fred Sammons, Inc. · Neurology device
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Jun 1982
Decision
8d
Days
Class 1
Risk

K821631 is an FDA 510(k) clearance for the PINCH GAUGE, 0-301 LBS.. Classified as Dynamometer, Nonpowered (product code HRW), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1250 - 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 Fred Sammons, Inc. devices

FDA 510(k) Submission Details - K821631

510(k) Number K821631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1982
Decision Date June 11, 1982
Days to Decision 8 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
140d faster than avg
Panel avg: 148d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

HRW Device Classification - Class 1, General Controls

Product Code HRW Dynamometer, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.