Cleared Traditional

K812609 - VASCULAB #VSC21

K812609 is an FDA 510(k) clearance for VASCULAB #VSC21, manufactured by Medasonics, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812609 · Medasonics, Inc. · Cardiovascular device
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Oct 1981
Decision
17d
Days
Class 2
Risk

K812609 is an FDA 510(k) clearance for the VASCULAB #VSC21. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Medasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - 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 Medasonics, Inc. devices

FDA 510(k) Submission Details - K812609

510(k) Number K812609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date October 02, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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.