510(k) Report

510(k) · Cleared

Recalled · 2010

Heartstream FR2 Aed, Model M3860A,M3861A

K003565510(k) SpecialCleared Dec 20, 200030-day reviewClass III21 CFR 870.5310Recalls 12

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Agilent Technologies, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Dec 20, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 12 times.

Decided
Dec 20, 2000
Review
30 days
Class
Class III
Product code
MKJ
Recalls
12
Predicates
0

10 later devices descend from it, 4 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2003: 1 descendant cleared2011: 1 descendant cleared2004: 2 descendants cleared, 1 with a Class I recall12002: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2013: 2 descendants cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK003565 Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc. · 2000
  2. Descendant · cites it directly · 3 of its ownK023854 Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 2003 · Recalled
  3. Descendant · cites it directly · 2 of its ownK111693 Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · Recalled
  4. Descendant · cites it directly · 2 of its ownK040904 Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 2004 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK041067 Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · Recalled (Class I)
  6. Descendant · 3 generations on · 1 of its ownK123881 Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 22009: 12011: 12012: 12013: 22015: 1
2002high 2 (2004) · low 0 (2005)2026

Class I recalls in this family

  • K041067 Heartsine Samaritan Pad2 generations on · 2004

Most influential descendants

Showing 5 of 10 · See all
  • K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 2003 · cites it directly3descendants
  • K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 2011 · cites it directly2descendants
  • K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 2004 · cites it directly2descendants
  • K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 2004 · 2 generations on2descendants
  • K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 2013 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003565Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc.2000—
+1K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc.20031
+1K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems20111
+1K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems20047
+2K041067Heartsine Samaritan PadHeartsine Technologies, Inc.2004Class I
+3K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.20131

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200421
200910
201110
201210
201320
201510
FIG. 1 — Lineage of K003565, 2000–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc.20033
K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems20112
K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems20042
K020984Accessaed, Semi-Automatic External DefibrillatorsAccess Cardiosystems, Inc.20020

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 22, 2010Not classifiedZ-0487-2011Nonconforming Material/ComponentA flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
Sep 22, 2010Not classifiedZ-0483-2011Nonconforming Material/ComponentA flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
Sep 22, 2010Not classifiedZ-0485-2011Nonconforming Material/ComponentA flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
Sep 22, 2010Not classifiedZ-0486-2011Nonconforming Material/ComponentA flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
Sep 22, 2010Not classifiedZ-0488-2011Nonconforming Material/ComponentA flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
Sep 22, 2010Not classifiedZ-0484-2011Nonconforming Material/ComponentA flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
May 28, 2010Not classifiedZ-0470-2011Nonconforming Material/ComponentFailure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
May 28, 2010Not classifiedZ-0472-2011Nonconforming Material/ComponentFailure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
May 28, 2010Not classifiedZ-0473-2011Nonconforming Material/ComponentFailure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
May 28, 2010Not classifiedZ-0471-2011Nonconforming Material/ComponentFailure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
Feb 28, 2007Not classifiedZ-0641-2007Nonconforming Material/ComponentFailure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation.
Dec 19, 2006Not classifiedZ-0308-2007Process designPotential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation

The 5 latest of 12 recalls; the web page lists all.

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 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K023854 (Heartsine Technologies, Inc., 2003) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKJ

48in 2025

2007: 72008: 132009: 82010: 42011: 112012: 102013: 72014: 112015: 62017: 42018: 202019: 252020: 522021: 412022: 192023: 242024: 272025: 482026 (partial year): 31
2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007: 69 days median2008: 141 days median2009: 165 days median2010: 250 days median2011: 36 days median2012: 197 days median2013: 191 days median2014: 196 days median2015: 156 days median
2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007: 122008: 242009: 372010: 352011: 72012: 5, 1 Class I2013: 42014: 24, 15 Class I2015: 12016: 2, 1 Class I2017: 6, 4 Class I2018: 32019: 6, 2 Class I2020: 22021: 42022: 32023: 112024: 52025: 12026 (partial year): 3
2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007: 3,9582008: 4,7522009: 6,7822010: 7,3992011: 8,1702012: 9,7322013: 14,9552014: 15,3992015: 16,1292016: 17,0622017: 16,6842018: 16,5912019: 16,8612020: 16,1972021: 16,3002022: 14,8672023: 13,7662024: 15,1092025: 13,315
2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007769123,958
200813141244,752
20098165376,782
20104250357,399
2011113678,170
2012101975 (1)9,732
20137191414,955
20141119624 (15)15,399
20156156116,129
20160—2 (1)17,062
20174—6 (4)16,684
201820—316,591
201925—6 (2)16,861
202052—216,197
202141—416,300
202219—314,867
202324—1113,766
202427—515,109
202548—113,315
202631—3—

More from Agilent Technologies, Inc.

105 FDA decisions under this applicant name. See the company

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Recent decisions in MKJ

The MKJ category page

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https://510kreport.com/device/K003565 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003565: Heartstream FR2 Aed, Model M3860A,M3861A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003565

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026