Cleared Traditional

K801719 - BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG

K801719 is an FDA 510(k) clearance for BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG, 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 11-day FDA review.

K801719 · Fred Sammons, Inc. · Neurology device
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Aug 1980
Decision
11d
Days
Class 1
Risk

K801719 is an FDA 510(k) clearance for the BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG. 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 August 4, 1980 after a review of 11 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 - K801719

510(k) Number K801719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 04, 1980
Days to Decision 11 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
138d faster than avg
Panel avg: 149d · This submission: 11d
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.

Regulatory Peers - HRW Dynamometer, Nonpowered

All 7
Devices cleared under the same product code (HRW) and FDA review panel - the closest regulatory comparables to K801719.
DIGIT-GRIP WITH LCD (DGR002)
K970870 · Nk Biotechnical Corp. · May 1997
PINCH GAUGE, 0-301 LBS.
K821631 · Fred Sammons, Inc. · Jun 1982
PINCH METER
K812343 · Fred Sammons, Inc. · Sep 1981
PINCH GUAGE
K772413 · Fred Sammons, Inc. · Jan 1978
DYNAMETER 50 LB.
K772415 · Fred Sammons, Inc. · Jan 1978
JAMAR DYNAMOMETEO BK-7498
K771288 · Fred Sammons, Inc. · Jul 1977