510(k) · Cleared
ClearedZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeller Power Products (Battery Beast, LLC) · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Nov 25, 2014 as substantially equivalent to K031987 (Cardiac Science, 2003) and 1 other predicate after a 196-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Nov 25, 2014
- Review
- 196 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K970741 (1997). 13 ancestors in all, the oldest K955628 (1996). No later device cites it as a predicate yet.
- Root · 7 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 6 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 5 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- 4 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- 3 generations backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- 2 generations backK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- 1 generation backK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- This deviceK141231 ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC) · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −6 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| −5 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| −4 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| −3 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| −2 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| −1 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| 0 (this device) | K141231 | ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery | Zeller Power Products (Battery Beast, LLC) | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 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.
Planning a device in MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K031987 | Powerheart Aed G3, Model 9300Summary page 4…70.5310 Automated External Defibrillator III (3) Identification of Predicate Devices - Cardiac Science battery packs 9141-001 and 9146-001 - Approved under K031987 and K040438 for their associated Cardiac Science PowerHeart® or Survivalink AED devices. Legally Marketed Predicate Devices… | 2003 |
| * | K040438 | Powerheart Aed G3ASummary page 4…Automated External Defibrillator III (3) Identification of Predicate Devices - Cardiac Science battery packs 9141-001 and 9146-001 - Approved under K031987 and K040438 for their associated Cardiac Science PowerHeart® or Survivalink AED devices. Legally Marketed Predicate Devices The ZP9141… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 9 of the 13 ancestors have a recall of any class.
- 5 other devices also cite its predicate K031987.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The ZP9141 is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9100 and 9200, or Survivalink Non-G3 9100 and 9200 AED’s and is designed to replace the Cardiac Science Model / Part Number 9141-001 battery pack. This battery pack has a shelf life of 5 years from the date of manufacture.
The ZP9146Y (or W) is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9300A and 9300E AED’s and is designed to replace the Cardiac Science Model / Part Number 9146-001 battery pack. This battery pack has a shelf life of 5 years from the date of manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141231: ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141231
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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