Panels › Cardiovascular › Product code DRM · Class 2
Compressor, Cardiac, External
Regulation 870.5200
0510(k)s in 12 months (45 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Michigan Instruments, Inc. | 6 | 3 |
| Zoll Circulation | 4 | 5 |
| Jolife AB | 5 | 3 |
| Pneupac , Ltd. | 4 | 0 |
| Revivant Corp. | 4 | 0 |
| Cardia Concepts Corp. | 3 | 0 |
| Defibtech, LLC | 2 | 1 |
| Huntleigh Technology, Inc. | 2 | 0 |
| Resuscitation International | 2 | 0 |
| Bdt Ent. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2026 | Jolife AB LUCAS 2
Model Number: 99576
Catalog Numbers: 99576-000024 and 99576-000011
UDI-DI code: 00883873904565
LUCAS 3
Model Number: 99576
Catalog Number: 99576-000043
UDI-DI code: 00883873861875
LUCAS 3.1
Open, Classified |
DRM | K090422 K161768 |
| Jun 20, 2025 | Jolife AB LUCAS 2, 3 and 3.1
LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous brea Open, Classified |
DRM | K090422 K161768 |
| Apr 11, 2025 | ZOLL Circulation, Inc. Brand Name: AutoPulse NXT Resuscitation System
Product Name: AutoPulse NXT Platform
Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1)
Software Version: Version 2.0.1
Product Description: Open, Classified |
DRM | K221700 |
| Aug 14, 2024 | Defibtech, LLC RMU-2000 Automated Chest Compression Device Open, Classified |
DRM | K211289 |
| Oct 21, 2022 | ZOLL Circulation, Inc. AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR Open, Classified |
DRM | K112998 |
| Feb 13, 2018 | Michigan Instruments, Inc. Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370
Product Usage:
The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cas Terminated |
DRM | K972525 |
| Jul 22, 2014 | Zoll Circulation, Inc. Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery.
The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a Terminated |
DRM | K011046 K022345 +2 |
| Jan 9, 2013 | Zoll Circulation, Inc. 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 Terminated |
DRM | K011046 K022345 +3 |
| Apr 7, 2011 | Zoll Circulation, Inc. Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085
Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fati Terminated |
DRM | K072527 |
| Mar 16, 2011 | Jolife AB LUCAS 2 Chest Compression System.
The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFI Terminated |
DRM | K090422 |
| Nov 14, 2006 | Michigan Instruments, Inc. Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000. Terminated |
DRM | K972525 |
| Nov 3, 2006 | Michigan Instruments, Inc. Michigan Instruments Thumper Mechanical CPR Device; Model 1007. Terminated |
DRM | K972525 |
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