AUTOPULSE RESUSCITATION SYSTEM MODEL 1000— 510(k) K112998

Name: FDA 510(k) clearance K112998
Creator: U.S. Food and Drug Administration
Published: 2012-03-15

Substantially Equivalent

Zoll Circulation

FDA 510(k) clearance K112998 for AUTOPULSE RESUSCITATION SYSTEM MODEL 1000, Substantially Equivalent on 2012-03-15. Applicant: Zoll Circulation. Device class: 2.

Clearance details

Applicant: Zoll Circulation
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
Advisory panel: Cardiovascular
Date received: 2011-10-07
Decision date: 2012-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRM

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K221700 — AutoPulse NXT Resuscitation System2023-03-09
K211289 — RMU-2000 Automated Chest Compression System2021-11-09
K173553 — LUCAS 3 Chest Compression System2018-02-08
K161768 — LUCAS 3 Chest Compression System2016-11-09
K153628 — ROSC-U Mini Chest Compressor (RMCC)2016-01-30

More clearances from Zoll Circulation

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Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K112998

K-number listed on FDA's recall record

Z-0118-2023 — AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPRClass II·Ongoing·ZOLL Circulation, Inc.·20220922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112998.

Data sourced from openFDA. This site is unofficial and independent of the FDA.