510(k) · Cleared
ClearedModification to Lucas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jolife AB · DRM Compressor, Cardiac, External
Cleared on Sep 28, 2006 as substantially equivalent to K053403 (Jolife AB, 2006) and 2 other predicates after a 43-day review. Its family tree reaches back 5 generations to 1985. 1 of the 14 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Sep 28, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- DRM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K851139 (1985). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 4 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 3 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 2 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- 1 generation backK053403 LUCASJolife AB · 2006
- This deviceK062401 Modification to LucasJolife AB · 2006
- Descendant · cites it directly · 5 of its ownK090422 LUCAS 2Jolife AB · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
- Descendant · 4 generations on · 0 of its ownK211289 RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK153628 ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211289 RMU-2000 Automated Chest Compression System4 generations on · 2021
Most influential descendants
Showing 5 of 6 · See all- K090422LUCAS 2Jolife AB · 2009 · cites it directly5descendants
- K161768LUCAS 3 Chest Compression SystemJolife AB · 2016 · 2 generations on2descendants
- K173553LUCAS 3 Chest Compression SystemJolife AB · 2018 · 3 generations on1descendant
- K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · 4 generations on0descendants
- K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −4 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −3 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −2 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| −1 | K053403 | LUCAS | Jolife AB | 2006 | — |
| 0 (this device) | K062401 | Modification to Lucas | Jolife AB | 2006 | — |
| +1 | K090422 | LUCAS 2 | Jolife AB | 2009 | 3 |
| +2 | K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016 | 2 |
| +3 | K173553 | LUCAS 3 Chest Compression System | Jolife AB | 2018 | — |
| +4 | K211289 | RMU-2000 Automated Chest Compression System | Defibtech, LLC | 2021 | Class I |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 1 |
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
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K053403 | LUCASSummary page 1…st compressor Classification name External cardiac compressor Product code DRM Predicatedevices * Lucas (K053403) * Thumper model 1007 (K972525) * Autopulse model… | 2006 |
| * | K972525 | ThumperSummary page 1…pressor Product code DRM Predicatedevices * Lucas (K053403) * Thumper model 1007 (K972525) * Autopulse model 100 (K(040453) \DC -019831/0000Gi -2350141 v2… | 1997 |
| * | K040453 | Autopulse Resuscitation System, Model 100Summary page 1…* Lucas (K053403) * Thumper model 1007 (K972525) * Autopulse model 100 (K(040453) \DC -019831/0000Gi -2350141 v2… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090422 | LUCAS 2 | 2009 | 5 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K090422 (Jolife AB, 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
LUCAS® External Cardiac Compressor 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.
LUCAS® must only be used in cases where manual chest compression would be used.
LUCAS® is only intended for temporary use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062401: Modification to Lucas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062401
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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