510(k) · Cleared
Recalled · Class II · 2012Autopulse Resuscitation System MODEL100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Circulation · DRM Compressor, Cardiac, External
Cleared on Dec 21, 2006 as substantially equivalent to K040453 (Revivant Corp., 2004) after a 17-day review. Its family tree reaches back 4 generations to 1985. 2 of the 17 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K851139 (1985). 5 ancestors in all. 11 later devices descend from it, 3 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 3 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 2 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 1 generation backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- This deviceK063602 Autopulse Resuscitation System MODEL100Zoll Circulation · 2006
- Descendant · cites it directly · 6 of its ownK073079 Thumper, Model: 1008Michigan Instruments, Inc. · 2008
- 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
- Descendant · 4 generations on · 1 of its ownK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
- Descendant · cites it directly · 1 of its ownK112998 Autopulse Resuscitation System Model 1000Zoll Circulation · 2012 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K073079Thumper, Model: 1008Michigan Instruments, Inc. · 2008 · cites it directly6descendants
- K090422LUCAS 2Jolife AB · 2009 · 2 generations on5descendants
- K161768LUCAS 3 Chest Compression SystemJolife AB · 2016 · 3 generations on2descendants
- K173553LUCAS 3 Chest Compression SystemJolife AB · 2018 · 4 generations on1descendant
- K112998Autopulse Resuscitation System Model 1000Zoll Circulation · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −3 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −2 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −1 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| 0 (this device) | K063602 | Autopulse Resuscitation System MODEL100 | Zoll Circulation | 2006 | — |
| +1 | K073079 | Thumper, Model: 1008 | Michigan Instruments, Inc. | 2008 | — |
| +2 | K090422 | LUCAS 2 | Jolife AB | 2009 | 3 |
| +3 | K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016 | 2 |
| +4 | K173553 | LUCAS 3 Chest Compression System | Jolife AB | 2018 | — |
| +1 | K112998 | Autopulse Resuscitation System Model 1000 | Zoll Circulation | 2012 | 1 |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K040453 | Autopulse Resuscitation System, Model 100Summary page 1…unct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse. Predicate Devices K040453 AutoPulSeim Resuscitation System Model 100 Device Description AutoPulse Resuscitation System Model 100 ("Device")… | 2004 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K073079 (Michigan Instruments, Inc., 2008) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K040453.
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/K063602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063602: Autopulse Resuscitation System MODEL100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063602
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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