510(k) · Cleared
ClearedVista Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novacor · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Jan 19, 2005 as substantially equivalent to K032466 (Ela Medical, Inc., 2003) and 6 other predicates after a 168-day review. Its family tree reaches back 4 generations to 1994. 46 later devices descend from it.
- Decided
- Jan 19, 2005
- Review
- 168 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K930806 (1994). 26 ancestors in all, the oldest K871344 (1987). 46 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 2 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 1 generation backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- This deviceK042108 Vista PlusNovacor · 2005
- Descendant · cites it directly · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · cites it directly · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- Descendant · 2 generations on · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- Descendant · 2 generations on · 23 of its ownK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · cites it directly40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · cites it directly30descendants
- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 2 generations on28descendants
- K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · 2 generations on26descendants
- K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −3 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −2 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −1 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| 0 (this device) | K042108 | Vista Plus | Novacor | 2005 | — |
| +1 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +1 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +2 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| +2 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| +2 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K032466 | SpiderviewSummary page 1…al name: Ambulatory ECG Holter Recorder Classification name : Electrocardiograph, Ambulatory with analysis algorithm. Predicate devices Spiderview - ELA MEDICAL Inc. - K032466 Cardio ID+(RZI153±) - ROZINN ELECTRONICS Inc. - K022540 Digitrak Plus - BRAEMER CORP - K993617 Device description: The VISTA PLU… | 2003 |
| * | K022540 | Cardio ID+(RZ153+)Summary page 1…name : Electrocardiograph, Ambulatory with analysis algorithm. Predicate devices Spiderview - ELA MEDICAL Inc. - K032466 Cardio ID+(RZI153±) - ROZINN ELECTRONICS Inc. - K022540 Digitrak Plus - BRAEMER CORP - K993617 Device description: The VISTA PLUS holter recorder is a miniature ambulatory ECO recorder… | 2002 |
| * | K993617 | Digitrakplus Holter RecorderSummary page 1…ith analysis algorithm. Predicate devices Spiderview - ELA MEDICAL Inc. - K032466 Cardio ID+(RZI153±) - ROZINN ELECTRONICS Inc. - K022540 Digitrak Plus - BRAEMER CORP - K993617 Device description: The VISTA PLUS holter recorder is a miniature ambulatory ECO recorder (ECG bolter) which can continuously re… | 1999 |
| * | K002817 | SynetecSummary page 4…Fax: +33 141 39 ('[ 99 SOFTWARE: Predicate devices for HolterSoft Ultirma: - Synetee, ELA Medical - K002817 - 20 10 PLUS Hotter for Windows, AGILENT/PHILIPS -K010949 - MARS Unity, MARQUETTE/GE -K99 1786 S ecificationsHolter… | 2001 |
| * | K010949 | 2010 Plus Holter for WindowsSummary page 4…Fax: +33 141 39 ('[ 99 SOFTWARE: Predicate devices for HolterSoft Ultirma: - Synetee, ELA Medical - K002817 - 20 10 PLUS Hotter for Windows, AGILENT/PHILIPS -K010949 - MARS Unity, MARQUETTE/GE -K99 1786 S ecificationsHolterSoft Ultirna… | 2001 |
| * | K991786 | Mars Unity Workstation with Heart Rate Variability (HRV) OptionSummary page 4…dicate devices for HolterSoft Ultirma: - Synetee, ELA Medical - K002817 - 20 10 PLUS Hotter for Windows, AGILENT/PHILIPS -K010949 - MARS Unity, MARQUETTE/GE -K99 1786 S ecificationsHolterSoft Ultirna… | 1999 |
| * | K020825 | King of Hearts Express + AF MonitorSummary page 5…Text Input J Predicate devices for HolterSoft Ultima Atrial Fibrillation Module King of Heart Ei ress + AF K, CARD GUARD/INSTROMEDIX, K020825 __ Device HolterSoft Ultima Amoue King of Heart Eixpre… | 2002 |
What descends from it? (46)
See all 464 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) | 2007 | 40 |
| K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 | 2007 | 30 |
| K140847 | Cardiospy Ecg Holter Systems | 2014 | 1 |
| K102111 | Medical Magnetic Tape Recorder | 2010 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K071641 (Medtronic, Inc., 2007) has gone furthest, with 40 descendants of its own.
- 3 other devices also cite its predicate K032466.
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?
Recorder:
Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channel, 6 days on two channels, 4 days on three channels. Recorded-data are intended to be analysed by holterSoft Ultima analysis on the ECG data.
Software:
HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042108: Vista Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042108
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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