Cleared Traditional

VA 1000 (K791380) - FDA 510(k) Clearance

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

K791380 · Vitatron Medical BV · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
57d
Days
Class 2
Risk

K791380 is an FDA 510(k) clearance for the VA 1000. Classified as Tester, Pacemaker Electrode Function (product code DTA), Class II - Special Controls.

Submitted by Vitatron Medical BV (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3720 - 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 Vitatron Medical BV devices

Submission Details

510(k) Number K791380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date September 19, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTA Tester, Pacemaker Electrode Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3720
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.