510(k) Report

510(k) · Cleared

Cleared

Brentwood Real Time ST and Arrhythmia Analysis Software Library

K013717510(k) TraditionalCleared Feb 6, 200290-day reviewClass II21 CFR 870.2340

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

Brentwood Medical Technology Corp. · DPS Electrocardiograph

Cleared on Feb 6, 2002 as substantially equivalent to K003621 (Agilent Technologies, Inc., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 72 later devices descend from it.

Decided
Feb 6, 2002
Review
90 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003621 (2000). 72 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared2020: 7 descendants cleared2015: 4 descendants cleared2019: 6 descendants cleared2017: 4 descendants cleared2018: 3 descendants cleared2011: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2021: 4 descendants cleared2026: 9 descendants cleared2022: 6 descendants cleared2024: 9 descendants cleared2025: 9 descendants cleared2023: 4 descendants clearedK003621 · ST/AR ST and Arrhythmia Software, Model Release D.0 · Agilent Technologies, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 9 descendants3 generations forward: 10 descendants4 generations forward: 15 descendants5 generations forward: 18 descendants6 generations forward: 11 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 2 descendants10 generations forward: 1 descendant K003621 · ST/AR ST and Arrhythmia Software, Model Release D.0 · Agilent Technologies, Inc. · 20000+5+10
  1. Root · 1 generation backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
  2. This deviceK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
  3. Descendant · cites it directly · 71 of its ownK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
  4. Descendant · cites it directly · 70 of its ownK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
  5. Descendant · 2 generations on · 32 of its ownK091075 Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009
  6. Descendant · 3 generations on · 31 of its ownK142681 ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014
  7. Descendant · 4 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 12011: 12014: 22015: 42016: 12017: 42018: 32019: 62020: 72021: 42022: 62023: 42024: 92025: 92026: 9
2005high 9 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 72 · See all
  • K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005 · cites it directly71descendants
  • K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc. · 2007 · cites it directly70descendants
  • K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009 · 2 generations on32descendants
  • K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014 · 3 generations on31descendants
  • K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 4 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003621ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc.2000—
0 (this device)K013717Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp.2002—
+1K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc.2005—
+1K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc.2007—
+2K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc.2009—
+3K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc.2014—
+4K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201110
201420
201540
201610
201740
201830
201960
202070
202140
202260
202340
202490
202590
202690
FIG. 1 — Lineage of K013717, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003621ST/AR ST and Arrhythmia Software, Model Release D.0
Summary page 1
…ST/AR ST and Arrhythmia Software, Release D.0”. The registered manufacturer of the cleared device is Agilent Technologies, Inc. of Andover, MA, and the 510(k) number is K003621. 1.4 DEVICE DESCRIPTION The Brentwood Real Time ST and Arrhythmia Analysis Software Library is an “object library”. An object l…
Agilent Technologies, Inc.2000—

Also cleared against K003621: 9 other devices →

What descends from it? (72)

See all 72

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

NumberDeviceApplicantDecidedDescendants
K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc.200571
K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc.200770

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?

  • Its one ancestor has no recall.
  • Of its descendants, K043380 (Monebo Technologies, Inc., 2005) has gone furthest, with 71 descendants of its own.
  • 9 other devices also cite its predicate K003621.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The manufacturer/integrator will ultimately identify the indications for use, depending on the nature of their device. The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients: QRS detection…

Read the full statement (103 words)

The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The manufacturer/integrator will ultimately identify the indications for use, depending on the nature of their device.

The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients:

QRS detection

ventricular ectopic beat detection (non-paced only)

rhythm call analysis, including asystole, bigeminy, couplets, irregular heart rate, pause or missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia

ST segment level measurement (adult patients only)

ventricular fibrillation detection

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003621

9 other devices cite the same predicate.

  • K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
  • K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
  • K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc. · 2007
  • K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems · 2007
  • K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 20051 recall
  • K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005

More from Brentwood Medical Technology Corp.

7 FDA decisions under this applicant name. See the company

  • K103640Midmark IqecgBrentwood Medical Technology Corp. · 20111 recall
  • K100913Iqvitals and Iqvitals SystemBrentwood Medical Technology Corp. · 2010
  • K052898Iqmark EZ StressBrentwood Medical Technology Corp. · 2006
  • K031466Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
  • K010505Telemed 12 Lead Resting Ecg Analysis LibraryBrentwood Medical Technology Corp. · 2001

Recent decisions in DPS

The DPS category page

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  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K013717 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013717: Brentwood Real Time ST and Arrhythmia Analysis Software Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013717

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026