510(k) · Cleared
ClearedFirstsave Biphasic Models 9200 and 9210
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Survivalink Corp. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jan 25, 1999 as substantially equivalent to K970481 (Survivalink Corp., 1997) and 1 other predicate after a 210-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Jan 25, 1999
- Review
- 210 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955628 (1996). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- This deviceK982264 Firstsave Biphasic Models 9200 and 9210Survivalink Corp. · 1999
- Descendant · cites it directly · 8 of its ownK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- Descendant · cites it directly · 6 of its ownK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK040637 Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K031987Powerheart Aed G3, Model 9300Cardiac Science · 2003 · cites it directly8descendants
- K040438Powerheart Aed G3ACardiac Science, Inc. · 2004 · cites it directly6descendants
- K040637Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · 2 generations on3descendants
- K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation · 2011 · 2 generations on2descendants
- K122758Powerheart G5 AedCardiac Science Corporation · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| 0 (this device) | K982264 | Firstsave Biphasic Models 9200 and 9210 | Survivalink Corp. | 1999 | — |
| +1 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| +1 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| +2 | K040637 | Powerheart Aed G3 Pro | Cardiac Science, Inc. | 2004 | 8 |
| +2 | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed… | Cardiac Science Corporation | 2011 | 2 |
| +3 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K970481 | V2Summary page 1…Name: SurVivaLink, Corporation 5430 Feltl Road Minncapoiis, MUN 55345 L-2. PREDICATE DEVICE FirstSave™ AED manufactured by SurVival.ink Corporation models 9100/9110 (K970481) and Forerunner AED manufactured by HeartStream models S, E and EM (K955628). L-3. INDICATION FOR USE The SurVivaLink’s FirstSa… | 1997 |
| * | K955628 | Fore Runner External Defibrillator/Defibrillator PadsSummary page 1…. PREDICATE DEVICE FirstSave™ AED manufactured by SurVival.ink Corporation models 9100/9110 (K970481) and Forerunner AED manufactured by HeartStream models S, E and EM (K955628). L-3. INDICATION FOR USE The SurVivaLink’s FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest b… | 1996 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K031987 (Cardiac Science, 2003) has gone furthest, with 8 descendants of its own.
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 FirstSave STAR Biphasic AED is intended for use by or on the order of a Physician or persons licensed by State law. It is designed for emergency treatment of cardiac arrest patients by trained personnel. The user assesses the patient’s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device. The FirstSave STAR Biphasic AED is intended to be used on patients older than eight years'.
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/K982264 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982264: Firstsave Biphasic Models 9200 and 9210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982264
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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