Cleared Traditional

K011046 - AUTOPULSE, MODEL 100

K011046 is an FDA 510(k) clearance for AUTOPULSE, manufactured by Revivant Corp.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K011046 · Revivant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
202d
Days
Class 2
Risk

K011046 is an FDA 510(k) clearance for the AUTOPULSE, MODEL 100. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Revivant Corp. (Sunnyvale, US). The FDA issued a Cleared decision on October 25, 2001 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Revivant Corp. devices

FDA 510(k) Submission Details - K011046

510(k) Number K011046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date October 25, 2001
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRM Device Classification - Class 2, Special Controls

Product Code DRM Compressor, Cardiac, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5200
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.

Regulatory Peers - DRM Compressor, Cardiac, External

All 14
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K011046.
RMU-2000 Automated Chest Compression System
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THUMPER
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HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K871271 · Huntleigh Technology, Inc. · Sep 1987