510(k) · Cleared
Recalled · Class II · 2022Autopulse Resuscitation System Model 1000
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 Mar 15, 2012 as substantially equivalent to K072527 (Zoll Circulation, 2008) and 5 other predicates after a 160-day review. Its family tree reaches back 5 generations to 1985. 1 of the 9 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 15, 2012
- Review
- 160 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to K851139 (1985). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 4 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 3 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 2 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- 1 generation backK063602 Autopulse Resuscitation System MODEL100Zoll Circulation · 2006 · Recalled
- This deviceK112998 Autopulse Resuscitation System Model 1000Zoll Circulation · 2012
- Descendant · cites it directly · 0 of its ownK221700 AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023 · Recalled (Class I)
Class I recalls in this family
- K221700 AutoPulse NXT Resuscitation Systemcites it directly · 2023
Most influential descendants
Showing 1 of 1 · See all- K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −4 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −3 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −2 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| −1 | K063602 | Autopulse Resuscitation System MODEL100 | Zoll Circulation | 2006 | 1 |
| 0 (this device) | K112998 | Autopulse Resuscitation System Model 1000 | Zoll Circulation | 2012 | — |
| +1 | K221700 | AutoPulse NXT Resuscitation System | Zoll Circulation, Inc. | 2023 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (6)
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 |
|---|---|---|---|
| * | K072527 | Autopulse Resuscitation System, Model 100Summary page 1…evice Name 510(k) # Decision Decision __ _ _ _ _ __ _Date K072527 03/19/2008 Substantially equivalent (SE) K063602 12/21/2006 Substantially… | 2008 |
| * | K063602 | Autopulse Resuscitation System MODEL100Summary page 1…_ _ __ _Date K072527 03/19/2008 Substantially equivalent (SE) K063602 12/21/2006 Substantially equivalent (SE) AutoPulse Resuscitation K040453 03/11/2004 Substantially… | 2006 |
| * | K040453 | Autopulse Resuscitation System, Model 100Summary page 1…ntially equivalent (SE) K063602 12/21/2006 Substantially equivalent (SE) AutoPulse Resuscitation K040453 03/11/2004 Substantially equivalent (SE) System Model 100 K032852 11/12/2003 Substantially… | 2004 |
| * | K032852 | Modification to: Autopulse Resuscitation System Model 100Summary page 1…ntially equivalent (SE) AutoPulse Resuscitation K040453 03/11/2004 Substantially equivalent (SE) System Model 100 K032852 11/12/2003 Substantially equivalent (SE) K022345 08/15/2002 Substantially… | 2003 |
| * | K022345 | Autopulse Resuscitation SystemSummary page 1…ntially equivalent (SE) System Model 100 K032852 11/12/2003 Substantially equivalent (SE) K022345 08/15/2002 Substantially equivalent (SE) K01 1046 10/25/2001 Substantially… | 2002 |
| * | K011046 | Autopulse, Model 100Summary page 1…ntially equivalent (SE) K022345 08/15/2002 Substantially equivalent (SE) K01 1046 10/25/2001 Substantially equivalent (SE) Indications for Use The AutoPulse Resuscitation System Model 100 is… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation System Class I | 2023 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2022 | Class II | Z-0118-2023 | Device Design | Due to increase in Li-Ion Battery failures |
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.
- K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K221700 (Zoll Circulation, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072527.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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/K112998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112998: Autopulse Resuscitation System Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112998
Report an extraction error
Are you the manufacturer?
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