Cleared Traditional

K112998 - AUTOPULSE RESUSCITATION SYSTEM MODEL 1000

K112998 is an FDA 510(k) clearance for AUTOPULSE RESUSCITATION SYSTEM MODEL 1000, manufactured by Zoll Circulation. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K112998 · Zoll Circulation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
160d
Days
Class 2
Risk

K112998 is an FDA 510(k) clearance for the AUTOPULSE RESUSCITATION SYSTEM MODEL 1000. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Zoll Circulation (San Jose, US). The FDA issued a Cleared decision on March 15, 2012 after a review of 160 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.

FDA 510(k) Submission Details - K112998

510(k) Number K112998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2011
Decision Date March 15, 2012
Days to Decision 160 days
Submission Type Traditional
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
35d slower than avg
Panel avg: 125d · This submission: 160d
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 30
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K112998.
LUCAS 3 Chest Compression System
K161768 · Jolife AB · Nov 2016
ROSC-U Mini Chest Compressor (RMCC)
K153628 · Resuscitation International, LLC · Jan 2016
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K141809 · Defibtech, LLC · Oct 2014
MINIATURIZE CHEST COMPRESSOR (MCC)
K102068 · Resuscitation International · Nov 2010
LUCAS 2
K090422 · Jolife AB · Jun 2009
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K072527 · Zoll Circulation · Mar 2008
K112998 · AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
Download PDF FDA Summary Zoll Circulation