510(k) · Cleared
Recalled · Class III · 2018Thumper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michigan Instruments, Inc. · DRM Compressor, Cardiac, External
Cleared on Oct 2, 1997 as substantially equivalent to K851139 (Michigan Instruments, Inc., 1985) after an 87-day review. Its family tree reaches back 1 generation to 1985. 1 of the 13 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 2, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851139 (1985). 11 later devices descend from it, 5 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- This deviceK972525 ThumperMichigan Instruments, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK053403 LUCASJolife AB · 2006
- Descendant · cites it directly · 6 of its ownK073079 Thumper, Model: 1008Michigan Instruments, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK062401 Modification to LucasJolife AB · 2006
- Descendant · 2 generations on · 5 of its ownK090422 LUCAS 2Jolife AB · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211289 RMU-2000 Automated Chest Compression System5 generations on · 2021
Most influential descendants
Showing 5 of 11 · See all- K053403LUCASJolife AB · 2006 · cites it directly7descendants
- K073079Thumper, Model: 1008Michigan Instruments, Inc. · 2008 · cites it directly6descendants
- K062401Modification to LucasJolife AB · 2006 · cites it directly6descendants
- K090422LUCAS 2Jolife AB · 2009 · 2 generations on5descendants
- K161768LUCAS 3 Chest Compression SystemJolife AB · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| 0 (this device) | K972525 | Thumper | Michigan Instruments, Inc. | 1997 | — |
| +1 | K053403 | LUCAS | Jolife AB | 2006 | — |
| +1 | K073079 | Thumper, Model: 1008 | Michigan Instruments, Inc. | 2008 | — |
| +1 | K062401 | Modification to Lucas | Jolife AB | 2006 | — |
| +2 | K090422 | LUCAS 2 | Jolife AB | 2009 | 3 |
| +3 | K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K851139 | Thumper Cardiopulmonary Resuscitator 1005Summary page 1…870.5200 . Substantially equivalent devices - Thumper® Model 1004: a “preamendment device.” Thumper® Model 1005: 510(k) Clearance dated May 15, 1985) reference number K851139. . Description of Thumper® Model 1007 The Thumper® Model 1007 is a pneumatically powered external cardiac compressor used on a p… | 1985 |
| * | — | Thumper® Model 1004 Named without a submission number |
What descends from it? (11)
See all 115 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 |
|---|---|---|---|---|
| Feb 13, 2018 | Class III | Z-1632-2018 | Nonconforming Material/Component | A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last ¿ to ¿ revolution of the knob could… |
| Sep 14, 2006 | Not classified | Z-0178-2007 | Other | Failure to initiate compressions when turned on. |
| Aug 4, 2006 | Not classified | Z-0119-2007 | Other | Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
This device is used 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972525: Thumper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972525
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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