510(k) · Cleared
ClearedHighpak-12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad Elektronik GmbH · MPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
Cleared on Jul 10, 2007 as substantially equivalent to K041459 (Medtronic Emergency Response Systems, Inc., 2004) and 4 other predicates after a 334-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Jul 10, 2007
- Review
- 334 days
- Class
- Class II
- Product code
- MPD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K921669 (1993). 29 ancestors in all, the oldest K802288 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 7 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 6 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 5 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 4 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 3 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 2 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- 1 generation backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- This deviceK062331 Highpak-12Ad Elektronik GmbH · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −7 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −6 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −5 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −4 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −3 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −2 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| −1 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| 0 (this device) | K062331 | Highpak-12 | Ad Elektronik GmbH | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 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 MPD? 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 MPD device
- #1 K253099 LIFEPAK 15 AC Power Adapter (41577-000333)score 13.8 · 13 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K041459 | Lifepak 12 Defibrillator/MonitorSummary page 1…) 06641-9258-0 Daniel Kraushaar Operations Manager The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator. Predicate Devices K041459 LifePak-12 Defibrillator =~ Medtronic Inc./Physio- Control K040775 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K0… | 2004 |
| * | K040775 | Lifepak 12Summary page 1…rechargeable lithium battery is intended for use in the LifePak-12 defibrillator. Predicate Devices K041459 LifePak-12 Defibrillator =~ Medtronic Inc./Physio- Control K040775 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K010918 LifePak-12 Defibrillator = Medtronic Inc./Physio- Control K00… | 2004 |
| * | K010918 | Lifepak 12 Defibrillator/Monitor SystemSummary page 1…defibrillator. Predicate Devices K041459 LifePak-12 Defibrillator =~ Medtronic Inc./Physio- Control K040775 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K010918 LifePak-12 Defibrillator = Medtronic Inc./Physio- Control K002445 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K991… | 2001 |
| * | K002445 | Lifepak 12DEFIBERLLATOR/Monitor SeriesSummary page 1…r =~ Medtronic Inc./Physio- Control K040775 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K010918 LifePak-12 Defibrillator = Medtronic Inc./Physio- Control K002445 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K991910 LifePak-12 Defibrillator =~ Medtronic Inc. /Physio- Control… | 2001 |
| * | K991910 | Lifepak 12 BiphasicSummary page 1…or = Medtronic Inc. /Physio- Control K010918 LifePak-12 Defibrillator = Medtronic Inc./Physio- Control K002445 LifePak-12 Defibrillator = Medtronic Inc. /Physio- Control K991910 LifePak-12 Defibrillator =~ Medtronic Inc. /Physio- Control… | 1999 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 13 of the 29 ancestors have a recall of any class.
- 3 other devices also cite its predicate K041459.
How does its category compare?
All MPD devicesMPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MPD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPD
Too few MPD 510(k)s in any year since 2007 to give a median.
Recalls per year · MPD
No recall names MPD since 2007.
Adverse event reports per year · MPD
11in 2025
MAUDE reports naming product code MPD, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HighPak® -12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
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/K062331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062331: Highpak-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062331
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