510(k) · Cleared
ClearedZynergy Zolution Electrophysiology Catheter, Model Z50000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zcv,Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Apr 6, 2000 as substantially equivalent to K933450 (Electro-Catheter Corp., 1995) and 1 other predicate after a 373-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Apr 6, 2000
- Review
- 373 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933450 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK933450 Closed Tip Multi-Electrode Catheter, ModificationElectro-Catheter Corp. · 1995
- This deviceK991060 Zynergy Zolution Electrophysiology Catheter, Model Z50000Zcv,Inc. · 2000
- Descendant · cites it directly · 0 of its ownK011847 Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory CableZynergy Cardio Vasular (Zcv), Inc. · 2001
Most influential descendants
Showing 1 of 1 · See all- K011847Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory CableZynergy Cardio Vasular (Zcv), Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933450 | Closed Tip Multi-Electrode Catheter, Modification | Electro-Catheter Corp. | 1995 | — |
| 0 (this device) | K991060 | Zynergy Zolution Electrophysiology Catheter, Model Z50000 | Zcv,Inc. | 2000 | — |
| +1 | K011847 | Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable | Zynergy Cardio Vasular (Zcv), Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · 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 |
|---|---|---|---|
| * | K933450 | Closed Tip Multi-Electrode Catheter, ModificationSummary page 1…leted per ISO10993 and FDA guidelines. Zynergy Zolution Electrophysiology Catheter is similar in design, composition and function to the Elecath Detector Series 510(k}# K933450, manufactured by Electro-Catheter Corporation and the Arrow Intracardiac Electrode Catheter Products, 510(k)# K953651 manufacture… | 1995 |
| * | K953651 | Diagnostic Electrophysiology Catheter SystemSummary page 1…and function to the Elecath Detector Series 510(k}# K933450, manufactured by Electro-Catheter Corporation and the Arrow Intracardiac Electrode Catheter Products, 510(k)# K953651 manufactured by Arrow Intemnational. COMPARATIVE FEATURES_ ZCV, Inc Electro-Catheter Co. Arrow Internationai Characteristics Zyn… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011847 | Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable | 2001 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K011847 (Zynergy Cardio Vasular (Zcv), Inc., 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for
temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
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/K991060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991060: Zynergy Zolution Electrophysiology Catheter, Model Z50000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991060
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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