510(k) · Cleared
ClearedEnertron CPR Jack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enertron Engineering Co. · DRM Compressor, Cardiac, External
Cleared on May 14, 2004 as substantially equivalent to K972525 (Michigan Instruments, Inc., 1997) and 1 other predicate after a 511-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- May 14, 2004
- Review
- 511 days
- Class
- Class II
- Product code
- DRM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851139 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −1 | K972525 | Thumper | Michigan Instruments, Inc. | 1997 | 3 |
| 0 (this device) | K024215 | Enertron CPR Jack | Enertron Engineering Co. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K972525 | ThumperSummary page 1…ENERTRON Various Models of CPR JACK * Common name of device: EXTERNAL CARDIAC COMPRESSOR * Predicate Device: THUMPER MODEL 1007, K972525 ELCARE GRIP, K010526 * Intended use The device is an external device th… | 1997 |
| * | K010526 | Modification to the GripSummary page 1…of device: EXTERNAL CARDIAC COMPRESSOR * Predicate Device: THUMPER MODEL 1007, K972525 ELCARE GRIP, K010526 * Intended use The device is an external device that is manually powered and is used to compress the chest… | 2001 |
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 19 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K972525.
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?
The device is an external device that is manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest for adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024215: Enertron CPR Jack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024215
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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