510(k) · Cleared
ClearedROSC-U Mini Chest Compressor (RMCC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resuscitation International, LLC · DRM Compressor, Cardiac, External
Cleared on Jan 30, 2016 as substantially equivalent to K102068 (Resuscitation International, 2010) and 1 other predicate after a 43-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- Jan 30, 2016
- Review
- 43 days
- Class
- Class II
- Product code
- DRM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K851139 (1985). 13 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 deviceK153628 ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016
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) | K153628 | ROSC-U Mini Chest Compressor (RMCC) | Resuscitation International, LLC | 2016 | — |
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 |
| 2010 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K102068 | Miniaturize Chest Compressor (MCC)Summary page 4…Class III Panel General & Plastic Surgery Product Code DRM Primary Predicate K102068 - Miniaturize Chest Compressor (MCC) Secondary Predicate K090422 - LUCAS 2 Description… | 2010 |
| * | K090422 | LUCAS 2Summary page 4…roduct Code DRM Primary Predicate K102068 - Miniaturize Chest Compressor (MCC) Secondary Predicate K090422 - LUCAS 2 Description The RMCC is an automated, portable chest compressor, which provides continuous… | 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 31 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 13 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. 2016, 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?
To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153628: ROSC-U Mini Chest Compressor (RMCC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153628
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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