510(k) Report

510(k) · Cleared

Cleared

Samaritan Pad Pak Defibrillation Electrode, Model SPP-301

K042088510(k) TraditionalCleared Sep 2, 200430-day reviewClass III21 CFR 870.5310

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

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

Cleared on Sep 2, 2004 as substantially equivalent to K012414 (Meridian Medical Technologies, Inc., 2002) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1991.

Decided
Sep 2, 2004
Review
30 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K911139 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2000: 1 other ancestorK911139 · Hewlett-Packard Models M1400A, M1402A & M1401A · Hewlett-Packard Co. · 1991K012414 · Prime Ecg System · Meridian Medical Technologies, Inc. · 20021990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K012414 · Prime Ecg System · Meridian Medical Technologies, Inc. · 2002K911139 · Hewlett-Packard Models M1400A, M1402A & M1401A · Hewlett-Packard Co. · 19910
  1. Root · 2 generations backK911139 Hewlett-Packard Models M1400A, M1402A & M1401AHewlett-Packard Co. · 1991
  2. 1 generation backK012414 Prime Ecg SystemMeridian Medical Technologies, Inc. · 2002
  3. This deviceK042088 Samaritan Pad Pak Defibrillation Electrode, Model SPP-301Heartsine Technologies, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K911139Hewlett-Packard Models M1400A, M1402A & M1401AHewlett-Packard Co.1991—
−1K012414Prime Ecg SystemMeridian Medical Technologies, Inc.2002—
0 (this device)K042088Samaritan Pad Pak Defibrillation Electrode, Model SPP-301Heartsine Technologies, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
FIG. 1 — Lineage of K042088, 1991–2004Source: 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), 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.

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
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012414Prime Ecg System
Summary page 1
…s have beenprmlae ____ ___ ____ ____ ____ ___ under Section 514 Predicate Devices * Meridian Technologies, PRIME ECG System (K012414) * Philips Medical Systems, OnsiteAED M5066A with M5071A pads (K020715) *Katecho, Inc., KDP-60A Adult Defib/Pace Multifunc…
Meridian Medical Technologies, Inc.2002—
*K020715Philips M5066A and M5068A
Summary page 1
…___ under Section 514 Predicate Devices * Meridian Technologies, PRIME ECG System (K012414) * Philips Medical Systems, OnsiteAED M5066A with M5071A pads (K020715) *Katecho, Inc., KDP-60A Adult Defib/Pace Multifunction Electrode (K002806) Substantial Equivalence The HeartSine Samaritan®…
Philips Medical Systems200212
*K002806K-Defib/Pace, Model KDP-60A
Summary page 1
…RIME ECG System (K012414) * Philips Medical Systems, OnsiteAED M5066A with M5071A pads (K020715) *Katecho, Inc., KDP-60A Adult Defib/Pace Multifunction Electrode (K002806) Substantial Equivalence The HeartSine Samaritan® PAD PAK defibrillation electrodes are substantially equivalent to the Meridian…
Katecho, Inc.2000—

Also cleared against K012414: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K012414.

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—

What is it indicated for?

The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, non-sterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

Indications for use as stated in the FDA summary.

Also cleared against K012414

2 other devices cite the same predicate.

  • K082312Prime Ecg System (with Enhanced Diagnostic Algorithm)Heartscape Technologies, Ltd. · 2008
  • K030104Prime Ecg SystemMeridian Medical Technologies, Inc. · 2003

More from Heartsine Technologies, Inc.

6 FDA decisions under this applicant name. See the company

  • K142709samaritan PAD 450PHeartsine Technologies, Inc. · 2015
  • K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 20131 recall
  • K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 20061 Class I recall
  • K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 20041 Class I recall
  • K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 20031 recall

Recent decisions in MKJ

The MKJ category page

  • P160015/S029AED 3 Defibrillator with Uni-PadzZOLL Medical Corporation · 2026
  • P160022/S056ZOLL R Series Monitor/DefibrillatorZOLL Medical Corporation · 2026
  • P160022/S054X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 2026
  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026

https://510kreport.com/device/K042088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042088: Samaritan Pad Pak Defibrillation Electrode, Model SPP-301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042088

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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