Cleared Traditional

K840978 - TOGGLE LOCKING PLIER

K840978 is an FDA 510(k) clearance for TOGGLE LOCKING PLIER, manufactured by Med-Tool, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K840978 · Med-Tool, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
50d
Days
Class 1
Risk

K840978 is an FDA 510(k) clearance for the TOGGLE LOCKING PLIER. Classified as Pliers, Surgical (product code HTC), Class I - General Controls.

Submitted by Med-Tool, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Med-Tool, Inc. devices

FDA 510(k) Submission Details - K840978

510(k) Number K840978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1984
Decision Date April 25, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

HTC Device Classification - Class 1, General Controls

Product Code HTC Pliers, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - HTC Pliers, Surgical

All 9
Devices cleared under the same product code (HTC) and FDA review panel - the closest regulatory comparables to K840978.
WIRE CUTTING PLIERS OR LINEMAN'S PLIERS
K854390 · Med-Tool, Inc. · Nov 1985
SLIP JOINT PLIERS
K844600 · Med-Tool, Inc. · Dec 1984
TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW
K844146 · Med-Tool, Inc. · Nov 1984
SLIP JOINT PLIER
K840979 · Med-Tool, Inc. · Apr 1984
HALF ROUND FILE
K840980 · Med-Tool, Inc. · Apr 1984
WIRE TWISTERS
K830721 · The Anspach Effort, Inc. · Apr 1983