Cleared Traditional

K830876 - PREP-CHECK

K830876 is the FDA 510(k) clearance for PREP-CHECK by General Devices. It is a Class 2 Cardiovascular device (product code KRC) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K830876 · General Devices · Cardiovascular device
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May 1983
Decision
61d
Days
Class 2
Risk

K830876 is an FDA 510(k) clearance for the PREP-CHECK. Classified as Tester, Electrode, Surface, Electrocardiographic (product code KRC), Class II - Special Controls.

Submitted by General Devices (Bergenfield, US). The FDA issued a Cleared decision on May 18, 1983 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2370 - 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.

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Submission Details

510(k) Number K830876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date May 18, 1983
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRC Tester, Electrode, Surface, Electrocardiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2370
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 Cardiovascular devices follow this clearance model.