510(k) · Cleared
Recalled · Class II · 2026LUCAS 2
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 Jun 17, 2009 as substantially equivalent to K062401 (Jolife AB, 2006) and 2 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1985. 1 of the 17 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 17, 2009
- Review
- 119 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 6 generations to K851139 (1985). 11 ancestors in all. 5 later devices descend from it, 3 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 5 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 4 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 3 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- 2 generations backK053403 LUCASJolife AB · 2006
- 1 generation backK062401 Modification to LucasJolife AB · 2006
- This deviceK090422 LUCAS 2Jolife AB · 2009
- Descendant · cites it directly · 2 of its ownK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
- Descendant · 3 generations on · 0 of its ownK211289 RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK153628 ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016
- Descendant · cites it directly · 0 of its ownK141809 Rmu-1000 Automated Chest Compression SystemDefibtech, LLC · 2014
Class I recalls in this family
- K211289 RMU-2000 Automated Chest Compression System3 generations on · 2021
Most influential descendants
Showing 5 of 5 · See all- K161768LUCAS 3 Chest Compression SystemJolife AB · 2016 · cites it directly2descendants
- K173553LUCAS 3 Chest Compression SystemJolife AB · 2018 · 2 generations on1descendant
- K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · 3 generations on0descendants
- K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016 · cites it directly0descendants
- K141809Rmu-1000 Automated Chest Compression SystemDefibtech, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −5 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −4 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −3 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| −2 | K053403 | LUCAS | Jolife AB | 2006 | — |
| −1 | K062401 | Modification to Lucas | Jolife AB | 2006 | — |
| 0 (this device) | K090422 | LUCAS 2 | Jolife AB | 2009 | — |
| +1 | K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016 | 2 |
| +2 | K173553 | LUCAS 3 Chest Compression System | Jolife AB | 2018 | — |
| +3 | K211289 | RMU-2000 Automated Chest Compression System | Defibtech, LLC | 2021 | Class I |
| +1 | K153628 | ROSC-U Mini Chest Compressor (RMCC) | Resuscitation International, LLC | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K062401 | Modification to LucasSummary page 1…gton DC 20004-1109 Phone: (202) 637-5813 February 13, 2009 LUCAS 2 Chest Compression System External cardiac compressor (21 CFR 870.5200) DRM » Lucas | cleared under K062401 » Thumper model 1008 cleared under K073079 ¢ Autopulse model 100 cleared under K072527 4 . [P .. [ . . OWEE PR NI A - JOLIFE A… | 2006 |
| * | K073079 | Thumper, Model: 1008Summary page 1…ebruary 13, 2009 LUCAS 2 Chest Compression System External cardiac compressor (21 CFR 870.5200) DRM » Lucas | cleared under K062401 » Thumper model 1008 cleared under K073079 ¢ Autopulse model 100 cleared under K072527 4 . [P .. [ . . OWEE PR NI A - JOLIFE AB, ideon Science Park, SE-223 70 Lund, Swede… | 2008 |
| * | K072527 | Autopulse Resuscitation System, Model 100Summary page 1…stem External cardiac compressor (21 CFR 870.5200) DRM » Lucas | cleared under K062401 » Thumper model 1008 cleared under K073079 ¢ Autopulse model 100 cleared under K072527 4 . [P .. [ . . OWEE PR NI A - JOLIFE AB, ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address:'smeelevagen 17 Tel: +46… | 2008 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2026 | Class II | Z-2161-2026 | Under Investigation by firm | Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service… |
| May 21, 2025 | Class II | Z-1998-2025 | Employee error | Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use. |
| Feb 8, 2011 | Not classified | Z-1664-2011 | Other | LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will… |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K161768 (Jolife AB, 2016) has gone furthest, with 2 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. 2009, 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?
LUCAS Chest Compression System 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 chest compressions are likely to help the patient.
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/K090422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090422: LUCAS 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090422
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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