510(k) · Cleared
Recalled · Class I · 2014Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartsine Technologies, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Dec 12, 2006 as substantially equivalent to K052057 (Medtronic Emergency Response Systems, Inc., 2006) after a 460-day review. Its family tree reaches back 7 generations to 1993. 1 of the 27 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Dec 12, 2006
- Review
- 460 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921669 (1993). 24 ancestors in all, the oldest K802288 (1980). 2 later devices descend from it, 1 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 5 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 4 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 3 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 2 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 1 generation backK052057 Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 2006 · Recalled
- This deviceK052465 Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and…Heartsine Technologies, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK142709 samaritan PAD 450PHeartsine Technologies, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −6 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −5 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −4 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −3 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −2 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −1 | K052057 | Lifepak 500 Automated External Defibrillator | Medtronic Emergency Response Systems, Inc. | 2006 | 3 |
| 0 (this device) | K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models… | Heartsine Technologies, Inc. | 2006 | — |
| +1 | K123881 | Heartsine Samaritan Pad 350P | Heartsine Technologies, Inc. | 2013 | 1 |
| +2 | K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K052057 | Lifepak 500 Automated External Defibrillator Cleared while this submission was under review Summary page 1…llators, automatic, external 74 MKJ Common/Usual Name: Automated external defibrillator and electrodes. 2. Equivalent legally marketed device: Medtronic LIFEPAK 500, K052057 3. Indications for Use: The samaritan Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmon… | 2006 |
| † | K042088 | Samaritan Pad Pak Defibrillation Electrode, Model SPP-301 | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123881 | Heartsine Samaritan Pad 350P | 2013 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2014 | Class II | Z-2115-2014 | Packaging process control | A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. |
| Sep 13, 2012 | Class I | Z-0124-2013 | Device Design | Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 24 ancestors have a recall of any class.
- Of its descendants, K123881 (Heartsine Technologies, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K052057.
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 samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.
The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg).
DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052465: Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052465
Report an extraction error
Are you the manufacturer?
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