510(k) · Cleared
Recalled · Class I · 2024RMU-2000 Automated Chest Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Defibtech, LLC · DRM Compressor, Cardiac, External
Cleared on Nov 9, 2021 as substantially equivalent to K173553 (Jolife AB, 2018) after a 195-day review. Its family tree reaches back 9 generations to 1985. 1 of the 15 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Nov 9, 2021
- Review
- 195 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K851139 (1985). 14 ancestors in all. No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 5 generations between
- 3 generations backK090422 LUCAS 2Jolife AB · 2009 · Recalled
- 2 generations backK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
- 1 generation backK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
- This deviceK211289 RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021
Show all 9 generations
- Root · 9 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 8 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 7 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 6 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- 5 generations backK053403 LUCASJolife AB · 2006
- 4 generations backK062401 Modification to LucasJolife AB · 2006
- 3 generations backK090422 LUCAS 2Jolife AB · 2009 · Recalled
- 2 generations backK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
- 1 generation backK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
- This deviceK211289 RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −8 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −7 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −6 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| −5 | K053403 | LUCAS | Jolife AB | 2006 | — |
| −4 | K062401 | Modification to Lucas | Jolife AB | 2006 | — |
| −3 | K090422 | LUCAS 2 | Jolife AB | 2009 | 3 |
| −2 | K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016 | 2 |
| −1 | K173553 | LUCAS 3 Chest Compression System | Jolife AB | 2018 | — |
| 0 (this device) | K211289 | RMU-2000 Automated Chest Compression System | Defibtech, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRM device
- #1 K221700 AutoPulse NXT Resuscitation Systemscore -7.5 · 6 generations · Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173553 | LUCAS 3 Chest Compression SystemSummary page 5…me Manufacturer Submission Number LUCAS3.1 Chest Compression System Jolife AB #k173553 The submission utilized a reference device, RMU - 1000, which has been previously cleared in K141809. 9. Device Description… | 2018 |
| † | K141809 | Rmu-1000 Automated Chest Compression System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2024 | Class I | Z-2543-2024 | Process control | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 14 ancestors have a recall of any class.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DRM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DRM
Too few DRM 510(k)s in any year since 2007 to give a median.
Recalls per year · DRM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRM
690in 2025
MAUDE reports naming product code DRM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 2 | — | 1 | 13 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 1 | 483 |
| 2013 | 0 | — | 0 | 1,268 |
| 2014 | 1 | — | 0 | 664 |
| 2015 | 0 | — | 0 | 674 |
| 2016 | 2 | — | 0 | 639 |
| 2017 | 0 | — | 0 | 679 |
| 2018 | 1 | — | 0 | 783 |
| 2019 | 0 | — | 0 | 706 |
| 2020 | 0 | — | 0 | 844 |
| 2021 | 1 | — | 0 | 755 |
| 2022 | 0 | — | 1 | 730 |
| 2023 | 1 | — | 0 | 765 |
| 2024 | 0 | — | 0 | 710 |
| 2025 | 0 | — | 0 | 690 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. The RMU-2000 must only be used in cases where chest compressions are likely to help the patient. The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients…
Read the full statement (107 words)
The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.
The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211289: RMU-2000 Automated Chest Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211289
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026