AUTOPULSE RESUSCITATION SYSTEM MODEL100— 510(k) K063602

Clearance details

Applicant

Zoll Circulation

Product code

Code DRM

Device class

Class 2

Regulation

21 CFR 870.5200

Advisory panel

Cardiovascular

Date received

2006-12-04

Decision date

2006-12-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Sunnyvale, CA, US

• 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

• K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER2014-10-03
• K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 10002012-03-15
• K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-45932010-10-12
• K072527 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 1002008-03-19

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 →

• Z-0658-2013 — AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.Class II·Terminated·Zoll Circulation, Inc.·20120808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063602.