510(k) · Cleared
Clearedsamaritan PAD 450P
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 Mar 27, 2015 as substantially equivalent to K123881 (Heartsine Technologies, Inc., 2013) after a 186-day review. Its family tree reaches back 9 generations to 1993. 2 of the 31 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 27, 2015
- Review
- 186 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921669 (1993). 30 ancestors in all, the oldest K802288 (1980). No later device cites it as a predicate yet. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations between
- 3 generations backK052057 Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 2006 · Recalled
- 2 generations backK052465 Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and…Heartsine Technologies, Inc. · 2006 · Recalled (Class I)
- 1 generation backK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · Recalled
- This deviceK142709 samaritan PAD 450PHeartsine Technologies, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 8 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 7 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 6 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 5 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 4 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 3 generations backK052057 Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 2006 · Recalled
- 2 generations backK052465 Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and…Heartsine Technologies, Inc. · 2006 · Recalled (Class I)
- 1 generation backK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · Recalled
- This deviceK142709 samaritan PAD 450PHeartsine Technologies, Inc. · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −8 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −7 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −6 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −5 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −4 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −3 | K052057 | Lifepak 500 Automated External Defibrillator | Medtronic Emergency Response Systems, Inc. | 2006 | 3 |
| −2 | K052465 | Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models… | Heartsine Technologies, Inc. | 2006 | Class I |
| −1 | K123881 | Heartsine Samaritan Pad 350P | Heartsine Technologies, Inc. | 2013 | 1 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K123881 | Heartsine Samaritan Pad 350PSummary page 4…tomated External Defibrillator Classification Regulation: 21 CFR 870.5310 Product Code: MKJ Classification: Class III Predicate Device: HeartSine samaritan® PAD 350P (K123881) The features and functions of the HeartSine samaritan PAD 450P (also called the SAM 450P) are substantially equivalent to those… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 30 ancestors have a recall of any class; 2 have a Class I recall.
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. 2015, 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 450P (also known as SAM 450P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs: . Unconscious . Not breathing . Without circulation The samaritan® PAD 450P 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.…
Read the full statement (134 words)
The HeartSine samaritan® PAD 450P (also known as SAM 450P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
. Unconscious
. Not breathing
. Without circulation
The samaritan® PAD 450P 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 450P is indicated for use on patients greater than 8 years old or over 55 Ibs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 450P is indicated for use on children between 1 and 8 years of age or up to 55 Ibs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).
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/K142709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142709: samaritan PAD 450P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142709
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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