Cleared Special

K040453 - AUTOPULSE RESUSCITATION SYSTEM, MODEL 100

K040453 is an FDA 510(k) clearance for AUTOPULSE RESUSCITATION SYSTEM, manufactured by Revivant Corp.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Special 510(k) pathway after a 17-day FDA review.

K040453 · Revivant Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
17d
Days
Class 2
Risk

K040453 is an FDA 510(k) clearance for the AUTOPULSE RESUSCITATION SYSTEM, 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 March 11, 2004 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040453

510(k) Number K040453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2004
Decision Date March 11, 2004
Days to Decision 17 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 38
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K040453.
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K062119 · Medical Products Mfg., LLC · Sep 2006
LUCAS
K053403 · Jolife AB · Feb 2006
ENERTRON CPR JACK
K024215 · Enertron Engineering Co. · May 2004
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K032852 · Revivant Corp. · Nov 2003
AUTOPULSE RESUSCITATION SYSTEM
K022345 · Revivant Corp. · Aug 2002
AUTOPULSE, MODEL 100
K011046 · Revivant Corp. · Oct 2001
K040453 · AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
Download PDF FDA Summary Revivant Corp.