510(k) · Cleared
Recalled · Class I · 2025AutoPulse NXT Resuscitation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Circulation, Inc. · DRM Compressor, Cardiac, External
Cleared on Mar 9, 2023 as substantially equivalent to K112998 (Zoll Circulation, 2012) after a 269-day review. Its family tree reaches back 6 generations to 1985. 1 of the 9 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Mar 9, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- DRM
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K851139 (1985). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
- 5 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
- 4 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
- 3 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
- 2 generations backK063602 Autopulse Resuscitation System MODEL100Zoll Circulation · 2006 · Recalled
- 1 generation backK112998 Autopulse Resuscitation System Model 1000Zoll Circulation · 2012 · Recalled
- This deviceK221700 AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K851139 | Thumper Cardiopulmonary Resuscitator 1005 | Michigan Instruments, Inc. | 1985 | — |
| −5 | K022345 | Autopulse Resuscitation System | Revivant Corp. | 2002 | 2 |
| −4 | K032852 | Modification to: Autopulse Resuscitation System Model 100 | Revivant Corp. | 2003 | 2 |
| −3 | K040453 | Autopulse Resuscitation System, Model 100 | Revivant Corp. | 2004 | 2 |
| −2 | K063602 | Autopulse Resuscitation System MODEL100 | Zoll Circulation | 2006 | 1 |
| −1 | K112998 | Autopulse Resuscitation System Model 1000 | Zoll Circulation | 2012 | 1 |
| 0 (this device) | K221700 | AutoPulse NXT Resuscitation System | Zoll Circulation, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 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.
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 K211289 RMU-2000 Automated Chest Compression Systemscore -9.3 · 9 generations · Class I recall
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 |
|---|---|---|---|
| * | K112998 | Autopulse Resuscitation System Model 1000Summary page 4…Classification Name: External Cardiac Compressor (21 CFR 870.5200) Product Code: DRM 510(k) Number: K112998 (Cleared: March 15, 2012) Device Description The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2025 | Class I | Z-1533-2025 | Process change control | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 7 of the 8 ancestors have a recall of any class.
How does its category compare?
All DRM devicesDRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient.
The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221700: AutoPulse NXT Resuscitation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221700
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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