510(k) · Cleared
ClearedMobile Battery Service Station (MBSS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad Elektronik GmbH · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Aug 27, 2003 as substantially equivalent to K973486 (Physio-Control Corp., 1998) and 1 other predicate after a 159-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Aug 27, 2003
- Review
- 159 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921669 (1993). 12 ancestors in all, the oldest K903644 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 2 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 1 generation backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- This deviceK030898 Mobile Battery Service Station (MBSS)Ad Elektronik GmbH · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −2 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −1 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| 0 (this device) | K030898 | Mobile Battery Service Station (MBSS) | Ad Elektronik GmbH | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 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.
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 |
|---|---|---|---|
| * | K973486 | Life Pak 12Summary page 1…the LifepakB, FastpakB and Fastpak [email protected] manufactured by Medtronic - Physio Control. Predicate Devices Lifepak 12 with Battery Charger - Medtronic-Physio Control K973486 Lifepak 12 with Battery Charger - Medtronic-Physio Control K990338 Device Description The MBSS overall dimensions are 30 cm x… | 1998 |
| * | K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemSummary page 1…c - Physio Control. Predicate Devices Lifepak 12 with Battery Charger - Medtronic-Physio Control K973486 Lifepak 12 with Battery Charger - Medtronic-Physio Control K990338 Device Description The MBSS overall dimensions are 30 cm x 20 c m x 10 cm. I t is available either as a table top model or wall… | 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 10 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 7 other devices also cite its predicate K973486.
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.
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 MBSS charging station is used to charge NiCd or. SLA batteries of the LifepakB, Fastpako and Fastpak 2 0 series manufactured by Medtronic - Physio Control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030898: Mobile Battery Service Station (MBSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030898
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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