510(k) · Cleared
Recalled · Class II · 2013Autopulse, Model 100
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 Oct 25, 2001 after a 202-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 18 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 25, 2001
- Review
- 202 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 2
- Predicates
- 0
17 later devices descend from it, 4 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- This deviceK011046 Autopulse, Model 100Revivant Corp. · 2001
- Descendant · cites it directly · 16 of its ownK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 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
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K022345Autopulse Resuscitation SystemRevivant Corp. · 2002 · cites it directly16descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011046 | Autopulse, Model 100 | Revivant Corp. | 2001 | — |
| +1 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 174 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?
- Of its descendants, K022345 (Revivant Corp., 2002) has gone furthest, with 16 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 | — |
https://510kreport.com/device/K011046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011046: Autopulse, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011046
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026