510(k) · Cleared
Recalled · 2008Firstsave Biphasic Model #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 Feb 22, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2001
- Review
- 30 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK010214 Firstsave Biphasic Model #9200 and 9210Survivalink Corp. · 2001
- Descendant · cites it directly · 11 of its ownK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- Descendant · 2 generations on · 10 of its ownK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- Descendant · 2 generations on · 8 of its ownK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 3 of its ownK040637 Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · cites it directly11descendants
- K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Cardiac Science, Inc. · 2003 · 2 generations on10descendants
- K031987Powerheart Aed G3, Model 9300Cardiac Science · 2003 · 2 generations on8descendants
- K040438Powerheart Aed G3ACardiac Science, Inc. · 2004 · 2 generations on6descendants
- K040637Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010214 | Firstsave Biphasic Model #9200 and 9210 | Survivalink Corp. | 2001 | — |
| +1 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| +2 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| +2 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| +2 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| +3 | K040637 | Powerheart Aed G3 Pro | Cardiac Science, Inc. | 2004 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 132 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 |
|---|---|---|---|---|
| Jan 23, 2008 | Not classified | Z-1714-2008 | Labeling design | Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011901 (Survivalink Corp., 2002) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K010214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010214: Firstsave Biphasic Model #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/K010214
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026