510(k) · Cleared
ClearedSpiderview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ela Medical, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Aug 22, 2003 as substantially equivalent to K022540 (Rozinn Electronics, Inc., 2002) and 2 other predicates after an 11-day review. Its family tree reaches back 3 generations to 1987. 56 later devices descend from it.
- Decided
- Aug 22, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K871344 (1987). 13 ancestors in all. 56 later devices descend from it, 4 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 deviceK032466 SpiderviewEla Medical, Inc. · 2003
- Descendant · cites it directly · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 3 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- Descendant · 3 generations on · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K042108Vista PlusNovacor · 2005 · cites it directly46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 3 generations on28descendants
- K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · 3 generations on26descendants
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) | K032466 | Spiderview | Ela Medical, Inc. | 2003 | — |
| +1 | K042108 | Vista Plus | Novacor | 2005 | — |
| +2 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +2 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +3 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| +3 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K022540 | Cardio ID+(RZ153+)Summary page 1…name: Ambulatory Holter Recorder Classification name: Electrocardiograph, Ambulatory (without analysis) MWJ (2 1 CFR 870.2800) Predicate devices: - Cardio ID+ (RZ153+) (K022540, ROZI" ELECTRONICS, INC.), - Digitrak Plus (Philips) (K993617, Braemar Corp.), - SyneFlash (K990727, ELA MEDICAL,… | 2002 |
| * | K993617 | Digitrakplus Holter RecorderSummary page 1…bulatory (without analysis) MWJ (2 1 CFR 870.2800) Predicate devices: - Cardio ID+ (RZ153+) (K022540, ROZI" ELECTRONICS, INC.), - Digitrak Plus (Philips) (K993617, Braemar Corp.), - SyneFlash (K990727, ELA MEDICAL, INC) and SyneFlash MMC Device description: The Spiderview TM Holter recorder… | 1999 |
| * | K990727 | Syneflash & SyneviewSummary page 1…R 870.2800) Predicate devices: - Cardio ID+ (RZ153+) (K022540, ROZI" ELECTRONICS, INC.), - Digitrak Plus (Philips) (K993617, Braemar Corp.), - SyneFlash (K990727, ELA MEDICAL, INC) and SyneFlash MMC Device description: The Spiderview TM Holter recorder is designed to acquire and store, in a… | 1999 |
What descends from it? (56)
See all 564 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 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K042108 (Novacor, 2005) has gone furthest, with 46 descendants of its own.
- 5 other devices also cite its predicate K022540.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 96-hour maximum period.
High-resolution recording of surface ECG data.
Note: Analysis of recorded Holter ECG data requires separately-supplied ELA Synetec, Syneview, or Synescope Holter analysis software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032466: Spiderview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032466
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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