Cleared Special

K022345 - AUTOPULSE RESUSCITATION SYSTEM

K022345 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 27-day FDA review.

K022345 · Revivant Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
27d
Days
Class 2
Risk

K022345 is an FDA 510(k) clearance for the AUTOPULSE RESUSCITATION SYSTEM. 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 August 15, 2002 after a review of 27 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 - K022345

510(k) Number K022345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2002
Decision Date August 15, 2002
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 K022345.
ENERTRON CPR JACK
K024215 · Enertron Engineering Co. · May 2004
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K040453 · Revivant Corp. · Mar 2004
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K032852 · Revivant Corp. · Nov 2003
AUTOPULSE, MODEL 100
K011046 · Revivant Corp. · Oct 2001
THUMPER
K972525 · Michigan Instruments, Inc. · Oct 1997
THUMPER CARDIOPULMONARY RESUSCITATOR
K962237 · Michigan Instruments, Inc. · Sep 1996
K022345 · AUTOPULSE RESUSCITATION SYSTEM
Download PDF FDA Summary Revivant Corp.