510(k) · Cleared
ClearedPremier 11 Holter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Monitoring Software · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Aug 25, 2006 as substantially equivalent to K911615 (Diagnostic Monitoring Software, 1992) and 1 other predicate after a 32-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Aug 25, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K871344 (1987). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 3 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 2 generations backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- 1 generation backK031466 Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
- This deviceK062088 Premier 11 HolterDiagnostic Monitoring Software · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −3 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −2 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| −1 | K031466 | Iqmark Digital Holter | Brentwood Medical Technology Corp. | 2003 | — |
| 0 (this device) | K062088 | Premier 11 Holter | Diagnostic Monitoring Software | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K911615 | Holter 24-Hour Ecg System, Model Number: DMS 300Summary page 1…ntification Number: MD6026579-956733 Legally marketed devices to which S.E. is claimed: The Premier 11 Holter system is essentially the same as the previously cleared K911615B Premier Holter system, except that (1) the software (other than the analysis) was changed to Windows, and (2) the Premier 11 acc… | 1992 |
| * | K031466 | Iqmark Digital HolterSummary page 1…k)s under 21 CFR 870.2800, Class I1: * Diagnostic Monitoring Software, Premier Holter system, K911615B. * Brentwood Medical Technology, IQmark Digital Holter, K031466 9.1 Description The Premier 1… | 2003 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
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 indications for use for 24-hour ambulatory ECG for this modified Premier 11 software and the listed predicate devices are for ECG evaluation of, but limited, to typical symptoms of chest pains, palpitations, dizziness, shortness of breath, and pacemaker. More specifically, indications for use include the following: . Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age; such as…
Read the full statement (124 words)
The indications for use for 24-hour ambulatory ECG for this modified Premier 11 software and the listed predicate devices are for ECG evaluation of, but limited, to typical symptoms of chest pains, palpitations, dizziness, shortness of breath, and pacemaker. More specifically, indications for use include the following:
. Assessment of symptoms that may be related to rhythm disturbances of the
heart in patients from pediatric to adult age; such as, palpitations.
• Assessment of risk in patients with or without symptoms or arrhythmia;
such as, patients with symptomatic or asymptomatic idiopathic hypertrophic
cardiomyopathy and postmyocardial infarction patients with left ventricular
dysfunction-
• Assessment of efficacy of anti-arrhythmic therapy.
* Assessment of pacemaker function.
.Detection of transient ST Depression, as well as Prinzmetal ST
Elevation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062088: Premier 11 Holter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062088
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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