510(k) · Cleared
Recalled · Class II · 2014Heartsine Samaritan Pad 350P
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 Jul 11, 2013 as substantially equivalent to K041067 (Heartsine Technologies, Inc., 2004) and 1 other predicate after a 206-day review. Its family tree reaches back 8 generations to 1993. 2 of the 31 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 11, 2013
- Review
- 206 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921669 (1993). 29 ancestors in all, the oldest K802288 (1980). 1 later device descends from it, 1 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 7 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 6 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 5 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 4 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 3 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 2 generations backK052057 Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 2006 · Recalled
- 1 generation backK052465 Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and…Heartsine Technologies, Inc. · 2006 · Recalled (Class I)
- This deviceK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK142709 samaritan PAD 450PHeartsine Technologies, Inc. · 2015
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K142709samaritan PAD 450PHeartsine Technologies, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −7 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −6 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −5 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −4 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −3 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −2 | K052057 | Lifepak 500 Automated External Defibrillator | Medtronic Emergency Response Systems, Inc. | 2006 | 3 |
| −1 | K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models… | Heartsine Technologies, Inc. | 2006 | Class I |
| 0 (this device) | K123881 | Heartsine Samaritan Pad 350P | Heartsine Technologies, Inc. | 2013 | — |
| +1 | 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 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K041067 | Heartsine Samaritan PadSummary page 2…pg 2 of 6 Predicate Device: The features and functions of the HeartSine samaritang PAD 350P are substantially equivalent to those of the HeartSine samaritan® PAD 300 (K041067) also known as SAM 300 and PAD300P (K052465) also known as SAM 300P. Device Description: The HeartSine samaritan& PAD (Public… | 2004 |
| * | K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Summary page 2…and functions of the HeartSine samaritang PAD 350P are substantially equivalent to those of the HeartSine samaritan® PAD 300 (K041067) also known as SAM 300 and PAD300P (K052465) also known as SAM 300P. Device Description: The HeartSine samaritan& PAD (Public Access Defibrillator) 350P (also called the… | 2006 |
| † | K023854 | Samaritan Aed, Model Sam-01 | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142709 | samaritan PAD 450P | 2015 | 0 |
Has anything in its family been recalled? (2 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 17 of the 29 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K142709 (Heartsine Technologies, Inc., 2015) has gone furthest, with 0 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. 2013, 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 HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs: * Unconscious * Not breathing * Without circulation The samaritan® PAD 350P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response…
Read the full statement (137 words)
The HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
* Unconscious
* Not breathing
* Without circulation
The samaritan® PAD 350P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program.
The samaritan® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123881: Heartsine Samaritan Pad 350P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123881
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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