RMU-2000 Automated Chest Compression System
FDA 510(k) clearance K211289 · decided 2021-11-09
Clearance details
- K-number
- K211289
- Device name
- RMU-2000 Automated Chest Compression System
- Applicant
- Defibtech, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-04-28
- Decision date
- 2021-11-09
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- DRM
- Device class
- 2
- Regulation number
- 870.5200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Guilford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AutoPulse NXT Resuscitation System (K221700) | Zoll Circulation, Inc. | 2023-03-09 |
| LUCAS 3 Chest Compression System (K173553) | Jolife AB | 2018-02-08 |
| LUCAS 3 Chest Compression System (K161768) | Jolife AB | 2016-11-09 |
| ROSC-U Mini Chest Compressor (RMCC) (K153628) | Resuscitation International, LLC | 2016-01-30 |
| RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809) | Defibtech, LLC | 2014-10-27 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (K112998) | Zoll Circulation | 2012-03-15 |
| MINIATURIZE CHEST COMPRESSOR (MCC) (K102068) | Resuscitation International | 2010-11-16 |
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527) | Zoll Circulation | 2008-03-19 |
| THUMPER, MODEL: 1008 (K073079) | Michigan Instruments, Inc. | 2008-02-14 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602) | Zoll Circulation | 2006-12-21 |
| MODIFICATION TO LUCAS (K062401) | Jolife AB | 2006-09-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RMU-2000 Automated Chest Compression Device recall (Z-2543-2024) | Defibtech, LLC | 2024-08-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (P160032/S013) | Defibtech, LLC | 2025-07-03 |
| Defibtech Lifeline, Defibtech Lifeline AUTO (P160032/S012) | Defibtech, LLC | 2024-12-05 |
| Defibtech Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E (P160032/S011) | Defibtech, LLC | 2024-09-06 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S010) | Defibtech, LLC | 2021-09-10 |
| Defibtech's Automated External Defibrillator (AED) System (P160032/S005) | Defibtech, LLC | 2021-06-10 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S002) | Defibtech, LLC | 2021-02-25 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S003) | Defibtech, LLC | 2020-11-18 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S009) | Defibtech, LLC | 2020-10-23 |