510(k) · Cleared
Recalled · Class I · 2012Heartsine Samaritan Pad
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 May 25, 2004 as substantially equivalent to K023854 (Heartsine Technologies, Inc., 2003) and 1 other predicate after a 32-day review. Its family tree reaches back 2 generations to 2000. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 25, 2004
- Review
- 32 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003565 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK003565 Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc. · 2000 · Recalled
- 1 generation backK023854 Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 2003 · Recalled
- This deviceK041067 Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004
- 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 |
|---|---|---|---|---|---|
| −2 | K003565 | Heartstream FR2 Aed, Model M3860A,M3861A | Agilent Technologies, Inc. | 2000 | 12 |
| −1 | K023854 | Samaritan Aed, Model Sam-01 | Heartsine Technologies, Inc. | 2003 | 1 |
| 0 (this device) | K041067 | Heartsine Samaritan Pad | Heartsine Technologies, Inc. | 2004 | — |
| +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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K023854 | Samaritan Aed, Model Sam-01Summary page 1…The Samaritan® PAD analysis algorithm is identical to the Samaritan®AED model which is in commercial distribution and which has been premarket cleared under K023854. The Samaritan® PAD functions identical to the earlier model SamaritaneAED. If a shock is required, the Samaritan® PA… | 2003 |
| * | K020715 | Philips M5066A and M5068ASummary page 3…3 === Predicate Device: HeartSine Technologies, Inc. Samaritan®AED (K023854) Phillips Medical Onsite M5066A (K020715) Substantial Equivalence: The HeartSine Samaritan® PAD is substantially equivalent to those of the previously c… | 2002 |
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 |
|---|---|---|---|---|
| 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 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K123881 (Heartsine Technologies, Inc., 2013) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The HeartSine Samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs:
* Unconscious
* Not breathing
- Without circulation
The Samaritan® PAD 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 is not currently indicated for use on children less than 8 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041067: Heartsine Samaritan Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041067
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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