Cleared Traditional

K813498 - MEDIFIX (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K813498 · Burron Medical Products, Inc. · Cardiovascular device
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Jan 1982
Decision
24d
Days
Class 2
Risk

K813498 is an FDA 510(k) clearance for the MEDIFIX. Classified as Manometer, Blood-pressure, Venous (product code KRK), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1140 - 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 Burron Medical Products, Inc. devices

Submission Details

510(k) Number K813498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1981
Decision Date January 07, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRK Manometer, Blood-pressure, Venous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1140
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.