PMA · Approved
Recalled · Class II · 2026HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartsine Technologies, Ltd. · MKJ Automated External Defibrillators (Non-Wearable)
Approved on Jan 12, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 297-day review. It has been recalled 7 times.
- Decided
- Jan 12, 2017
- Review
- 297 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 7
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160008 has 32 supplements since 2018: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 6 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 5 |
| 2026 | 4 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKJ? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2026 | Class III | Z-3270-2026 | Process control | Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. |
| Jul 27, 2026 | Class II | Z-3120-2026 | Process control | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. |
| Sep 18, 2025 | Class II | Z-0288-2026 | Under Investigation by firm | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
| Jun 30, 2025 | Class II | Z-2174-2025 | Process change control | Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) |
| Apr 26, 2023 | Class II | Z-2143-2023 | Process control | Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly. |
| Feb 1, 2023 | Class II | Z-1217-2023 | Process control | Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. |
| Jan 13, 2022 | Class III | Z-0745-2022 | Process control | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has 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. 2017, 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 | — |
https://510kreport.com/device/P160008 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160008: HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160008
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026