510(k) · Cleared
Recalled · 2004Firstsave Star Biphasic, Model 9210/9200
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 Feb 1, 2002 as substantially equivalent to K010214 (Survivalink Corp., 2001) and 1 other predicate after a 228-day review. Its family tree reaches back 3 generations to 1997. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 1, 2002
- Review
- 228 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970741 (1997). 4 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 2 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 1 generation backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- This deviceK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002
- Descendant · cites it directly · 10 of its ownK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Cardiac Science, Inc. · 2003 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −2 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| −1 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| 0 (this device) | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | — |
| +1 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 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 |
|---|---|---|---|
| * | K010214 | Firstsave Biphasic Model #9200 and 9210Summary page 1…4 Applicant Applicant’s Name: Survivalink, Corporation 5430 Feltl Road Minneapolis, MN 55343 N-2. PREDICATE DEVICES FirstSave STAR Biphasic AED, models 9200 and 9210 (K010214), Powerheart AED (K993533) N-3. INDICATION FOR USE The FirstSave STAR Biphasic AED is intended to be used by personnel who hav… | 2001 |
| * | K993533 | Powerheart AecdSummary page 1…me: Survivalink, Corporation 5430 Feltl Road Minneapolis, MN 55343 N-2. PREDICATE DEVICES FirstSave STAR Biphasic AED, models 9200 and 9210 (K010214), Powerheart AED (K993533) N-3. INDICATION FOR USE The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its opera… | 2000 |
What descends from it? (11)
See all 113 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2004 | Not classified | Z-1033-04 | Other | Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on. |
| May 24, 2004 | Not classified | Z-1034-04 | Other | Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K022929 (Cardiac Science, Inc., 2003) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K010214.
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 to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to…
Read the full statement (111 words)
The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm¹. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The device is intended for use on persons older than eight years of age².
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/K011901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011901: Firstsave Star Biphasic, Model 9210/9200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011901
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026