Cleared Traditional

TORQUE HEX WRENCH (K875147) - FDA 510(k) Clearance

Class I Cardiovascular device.

K875147 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jan 1988
Decision
43d
Days
Class 1
Risk

K875147 is an FDA 510(k) clearance for the TORQUE HEX WRENCH. Classified as Tools, Pacemaker Service (product code DTF), Class I - General Controls.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 27, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3730 - the FDA cardiovascular device oversight 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K875147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date January 27, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTF Tools, Pacemaker Service
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3730
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.