510(k) · Cleared
Recalled · 2005Samaritan Aed, Model Sam-01
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 Feb 14, 2003 as substantially equivalent to K003565 (Agilent Technologies, Inc., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 14, 2003
- Review
- 87 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003565 (2000). 3 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK003565 Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc. · 2000 · Recalled
- This deviceK023854 Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK041067 Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK142709 samaritan PAD 450PHeartsine Technologies, Inc. · 2015
Class I recalls in this family
- K041067 Heartsine Samaritan Padcites it directly · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003565 | Heartstream FR2 Aed, Model M3860A,M3861A | Agilent Technologies, Inc. | 2000 | 12 |
| 0 (this device) | K023854 | Samaritan Aed, Model Sam-01 | Heartsine Technologies, Inc. | 2003 | — |
| +1 | K041067 | Heartsine Samaritan Pad | Heartsine Technologies, Inc. | 2004 | Class I |
| +2 | K123881 | Heartsine Samaritan Pad 350P | Heartsine Technologies, Inc. | 2013 | 1 |
| +3 | K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K003565 | Heartstream FR2 Aed, Model M3860A,M3861ASummary page 1…gy Predicate Device: The features and functions of the Heartsine Samaritan@AED are substantially equivalent to those of the Phillips Heartstream FR2 (K003565). Device Description: The HeartSine Samaritan@AEDis a small, portable, battery operated automated external de… | 2000 |
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 |
|---|---|---|---|
| K041067 | Heartsine Samaritan Pad Class I | 2004 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2005 | Not classified | Z-1046-05 | Device Design | Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition. |
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.
- K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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@AEDis indicated for use on victims of cardiac arrest who are exhibiting the following signs:
Unconscious
Not breathing
Without circulation
The Samaritan@AEDis intended for use by personnel who have been trained in its operation. Users should have received training in basic life support I AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan@AED 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/K023854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023854: Samaritan Aed, Model Sam-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023854
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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