510(k) · Cleared
ClearedIqmark Digital Holter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brentwood Medical Technology Corp. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Jun 11, 2003 as substantially equivalent to K914577 (Precision Health Care Systems, Inc., 1992) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 1987. 6 later devices descend from it.
- Decided
- Jun 11, 2003
- Review
- 34 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K871344 (1987). 10 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 2 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 1 generation backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- This deviceK031466 Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
- Descendant · cites it directly · 3 of its ownK063035 Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK073147 Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007
- Descendant · 2 generations on · 1 of its ownK083828 Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM…Transoma · 2009
- Descendant · cites it directly · 0 of its ownK142693 ZywieAI Software LibraryZywie, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK091206 Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna…Transoma Medical · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007 · cites it directly3descendants
- K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007 · 2 generations on2descendants
- K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma · 2009 · 2 generations on1descendant
- K142693ZywieAI Software LibraryZywie, Inc. · 2015 · cites it directly0descendants
- K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −2 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −1 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| 0 (this device) | K031466 | Iqmark Digital Holter | Brentwood Medical Technology Corp. | 2003 | — |
| +1 | K063035 | Sleuth Implantable Ecg Monitoring System | Transnoma Medical, Inc. | 2007 | — |
| +2 | K073147 | Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08 | Transoma Medical | 2007 | — |
| +2 | K083828 | Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna… | Transoma | 2009 | — |
| +1 | K142693 | ZywieAI Software Library | Zywie, Inc. | 2015 | — |
| +3 | K091206 | Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal… | Transoma Medical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2015 | 1 | 0 |
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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914577 | Rhythmscan Precision 6000Summary page 1…(Per 21 CFR 870.2800) Legally marketed devices to which Substantial Equivalence is claimed: Rhythmscan Precision 6000 - 5 1O(k) K914577, May 08, 1992 SyneviewTMHolter ECG System ( 5 1O(k) K990727, ELA Medical Inc.) OF DEVICE: DESCRIPTION… | 1992 |
| * | K990727 | Syneflash & SyneviewSummary page 1…eted devices to which Substantial Equivalence is claimed: Rhythmscan Precision 6000 - 5 1O(k) K914577, May 08, 1992 SyneviewTMHolter ECG System ( 5 1O(k) K990727, ELA Medical Inc.) OF DEVICE: DESCRIPTION The IQrnurk Digitul Holter is a software program that analyzes r… | 1999 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K063035 (Transnoma Medical, Inc., 2007) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K914577.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not…
Read the full statement (122 words)
The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report.
The IQmark Digital Holter is intended to be used only by physicians or on the order of a physician.
The intended use of the IQmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031466: Iqmark Digital Holter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031466
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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