510(k) Report

510(k) · Cleared

Cleared

Medilog Darwin Holter Analysis

K053369510(k) TraditionalCleared Dec 22, 200517-day reviewClass II21 CFR 870.1425

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

Huntleigh Healthcare · DQK Computer, Diagnostic, Programmable

Cleared on Dec 22, 2005 as substantially equivalent to K002544 (Oxford Instruments, 2000) after a 17-day review. Its family tree reaches back 1 generation to 2000. 13 later devices descend from it.

Decided
Dec 22, 2005
Review
17 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002544 (2000). 13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2010: 2 descendants cleared2011: 3 descendants cleared2023: 3 descendants cleared2025: 2 descendants cleared2020: 1 descendant cleared2022: 1 descendant clearedK002544 · Medilog Excel 2 - Holter Management System · Oxford Instruments · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K002544 · Medilog Excel 2 - Holter Management System · Oxford Instruments · 20000+5
  1. Root · 1 generation backK002544 Medilog Excel 2 - Holter Management SystemOxford Instruments · 2000
  2. This deviceK053369 Medilog Darwin Holter AnalysisHuntleigh Healthcare · 2005
  3. Descendant · cites it directly · 12 of its ownK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
  4. Descendant · 2 generations on · 6 of its ownK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
  5. Descendant · 3 generations on · 5 of its ownK110525 Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011
  6. Descendant · 4 generations on · 3 of its ownK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
  7. Descendant · 2 generations on · 3 of its ownK092785 Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder &…Vasomedical, Inc. · 2010

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 32020: 12022: 12023: 32025: 2
2009high 3 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 13 · See all
  • K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc. · 2009 · cites it directly12descendants
  • K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010 · 2 generations on6descendants
  • K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011 · 3 generations on5descendants
  • K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020 · 4 generations on3descendants
  • K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc. · 2010 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002544Medilog Excel 2 - Holter Management SystemOxford Instruments2000—
0 (this device)K053369Medilog Darwin Holter AnalysisHuntleigh Healthcare2005—
+1K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.2009—
+2K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix2010—
+3K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.2011—
+4K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs2020—
+2K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis…Vasomedical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201130
202010
202210
202330
202520
FIG. 1 — Lineage of K053369, 2000–2025Source: 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 DQK? 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 DQK device

  1. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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
*K002544Medilog Excel 2 - Holter Management System
Summary page 1
…Predicate device(s) to which substantial equivalence is claimed Device Name: Medilog Excel 3 Holter Management System. 510(k) Number: K002544, approved by FDA on 13th September 2000. Device Classification: Class II. Regulation Number: 21 CFR 870.1425 Prog…
Oxford Instruments2000—

Also cleared against K002544: 3 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.200912

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, K083820 (Vasomedical, Inc., 2009) has gone furthest, with 12 descendants of its own.
  • 3 other devices also cite its predicate K002544.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

What is it indicated for?

Medilog Darwin Holter Analysis is indicated for the replay and analysis of ECG data prerecorded on Medilog series ambulatory recorders.

It is indicated for use in the analysis, display, editing and report generation of ambulatory ECG data as part of the assessment of cardiac rhythm disturbance and myocardial ischaemia. Typically it is intended for patients requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.

Indications for use as stated in the FDA summary.

Also cleared against K002544

3 other devices cite the same predicate.

  • K042799QRS-Card Cardiology SuitePulse Biomedical, Inc. · 2004
  • K042463Holter PlusRozinn Electronics, Inc. · 2004
  • K021176Compumedics Somte SystemCompumedics Limited · 2003

More from Huntleigh Healthcare

2 FDA decisions under this applicant name. See the company

  • K121108Dopplex AbilityHuntleigh Healthcare · 2013

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The DQK category page

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https://510kreport.com/device/K053369 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053369: Medilog Darwin Holter Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053369

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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