510(k) · Cleared
ClearedPhilips Heartstart Smartpads Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 26, 2008 as substantially equivalent to K050004 (Philips Medical Systems, 2005) after a 148-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 148 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020715 (2002). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020715 Philips M5066A and M5068APhilips Medical Systems · 2002 · Recalled
- 1 generation backK050004 Philips Heartstart FRX Defibrillator, Model 861304Philips Medical Systems · 2005 · Recalled
- This deviceK072812 Philips Heartstart Smartpads IiiPhilips Medical Systems · 2008
- Descendant · cites it directly · 2 of its ownK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK130684 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK120350 Extended Life BatteryAed Battery Exchange, LLC · 2012
Most influential descendants
Showing 3 of 3 · See all- K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · cites it directly2descendants
- K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2013 · 2 generations on0descendants
- K120350Extended Life BatteryAed Battery Exchange, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020715 | Philips M5066A and M5068A | Philips Medical Systems | 2002 | 12 |
| −1 | K050004 | Philips Heartstart FRX Defibrillator, Model 861304 | Philips Medical Systems | 2005 | 7 |
| 0 (this device) | K072812 | Philips Heartstart Smartpads Iii | Philips Medical Systems | 2008 | — |
| +1 | K111693 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2011 | 1 |
| +2 | K130684 | Philips Heartstart FR3 Automated External Defibrillator | Philips Medical Systems | 2013 | 1 |
| +2 | K120350 | Extended Life Battery | Aed Battery Exchange, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K050004 | Philips Heartstart FRX Defibrillator, Model 861304Summary page 1…SmartPads 11 Multifunction Defibrillation Pads, cleared as a part of the Philips Medical System HeartStart model FRx Automated External Defibrillator (K050004). The design and the intended use of the HeartStart SmartPad Ill is substantially equivalent in safety and per… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111693 | Philips Heartstart FR3 Automated External Defibrillator | 2011 | 2 |
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 6 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K111693 (Philips Medical Systems, 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K050004.
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. 2008, this device’s year, is highlighted.
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 Philips HeartStart SmartPads III is indicated for external defibrillation, pacing, monitoring and cardioversion.
The SmartPads III is intended for adults and children over 8 years of age or greater than 55 pounds (25kg) with all compatible defibrillators. 'he SmartPads III is also intended for children of all ages when used with a Philips Medical System model FRx equipped with an Infant/Child Key or with other compatible defibrillators which incorporate adjustable defibrillation energy functionality
The device is non-sterile and single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072812: Philips Heartstart Smartpads Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072812
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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