510(k) · Cleared
ClearedRmu-1000 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 Oct 27, 2014 as substantially equivalent to K090422 (Jolife AB, 2009) after a 112-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- Oct 27, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- DRM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K851139 (1985). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 6 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 5 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 4 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- 3 generations backK053403 LUCASJolife AB · 2006
- 2 generations backK062401 Modification to LucasJolife AB · 2006
- 1 generation backK090422 LUCAS 2Jolife AB · 2009 · Recalled
- This deviceK141809 Rmu-1000 Automated Chest Compression SystemDefibtech, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −6 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −5 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −4 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| −3 | K053403 | LUCAS | Jolife AB | 2006 | — |
| −2 | K062401 | Modification to Lucas | Jolife AB | 2006 | — |
| −1 | K090422 | LUCAS 2 | Jolife AB | 2009 | 3 |
| 0 (this device) | K141809 | Rmu-1000 Automated Chest Compression System | Defibtech, LLC | 2014 | — |
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.
Planning a device in DRM? 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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K090422 | LUCAS 2Summary page 5…er the following: Proprietary Name Manufacturer Submission Number LUCAS2 Chest Compression System Jolife AB #K090422 9. Device Description The RMU-1000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090422.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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-1000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) 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 as stated in the FDA summary.
https://510kreport.com/device/K141809 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141809: Rmu-1000 Automated Chest Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141809
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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