510(k) · Cleared
Recalled · Class II · 2013Autopulse Resuscitation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revivant Corp. · DRM Compressor, Cardiac, External
Cleared on Aug 15, 2002 as substantially equivalent to K011046 (Revivant Corp., 2001) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1985. 2 of the 19 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 15, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851139 (1985). 2 ancestors in all. 16 later devices descend from it, 3 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- This deviceK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002
- Descendant · cites it directly · 15 of its ownK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- Descendant · cites it directly · 14 of its ownK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- Descendant · 2 generations on · 11 of its ownK063602 Autopulse Resuscitation System MODEL100Zoll Circulation · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK053403 LUCASJolife AB · 2006
- Descendant · 3 generations on · 6 of its ownK073079 Thumper, Model: 1008Michigan Instruments, Inc. · 2008
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K032852Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · cites it directly15descendants
- K040453Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · cites it directly14descendants
- K063602Autopulse Resuscitation System MODEL100Zoll Circulation · 2006 · 2 generations on11descendants
- K053403LUCASJolife AB · 2006 · 2 generations on7descendants
- K073079Thumper, Model: 1008Michigan Instruments, Inc. · 2008 · 3 generations on6descendants
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) | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | — |
| +1 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| +1 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| +2 | K063602 | Autopulse Resuscitation System MODEL100 | Zoll Circulation | 2006 | 1 |
| +2 | K053403 | LUCAS | Jolife AB | 2006 | — |
| +3 | K073079 | Thumper, Model: 1008 | Michigan Instruments, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 1 |
| 2023 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K011046 | Autopulse, Model 100 | 2001 |
| * | K851139 | Thumper Cardiopulmonary Resuscitator 1005Summary page 1…ses of clinical death as defined by lack of spontaneous breathing and pulse. Predicate Devices KO1 1046 AutoPulse Model 100 IS851139 Thumper Model 1005 Device Description AutoPulse Resuscitation System Model 100 (“Device”) is an automated, portable… | 1985 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2013 | Class III | Z-2090-2014 | Labeling Change Control | Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product. |
| Aug 8, 2012 | Class II | Z-0658-2013 | Employee error | Complaints associated with an unexpected stop in AutoPulse compressions. |
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.
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?
The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022345: Autopulse Resuscitation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022345
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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