510(k) · Cleared
ClearedZynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zynergy Cardio Vasular (Zcv), Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jul 13, 2001 as substantially equivalent to K991060 (Zcv,Inc., 2000) after a 30-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 13, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933450 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK933450 Closed Tip Multi-Electrode Catheter, ModificationElectro-Catheter Corp. · 1995
- 1 generation backK991060 Zynergy Zolution Electrophysiology Catheter, Model Z50000Zcv,Inc. · 2000
- This deviceK011847 Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory CableZynergy Cardio Vasular (Zcv), Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933450 | Closed Tip Multi-Electrode Catheter, Modification | Electro-Catheter Corp. | 1995 | — |
| −1 | K991060 | Zynergy Zolution Electrophysiology Catheter, Model Z50000 | Zcv,Inc. | 2000 | — |
| 0 (this device) | 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 |
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 13.7 · 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? (1)
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 |
|---|---|---|---|
| * | K991060 | Zynergy Zolution Electrophysiology Catheter, Model Z50000Summary page 1…y Catheter With Z9000 Accessory Cable is substantially equivalent to Zynergy Zolution Electrophysiology Catheter Model 25000 and Cable Model Z9000 as described in 510(k) K991060, which is cleared by the FDA on April 6, 2000. 4. Device Description: Same as the predicate Zynergy Zolution Electrophysiology… | 2000 |
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 6 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
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?
Identical to the indications of the predicate Zynergy Zolution catheters and cables cleared through 510(k) K991060, Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation 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/K011847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011847: Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011847
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026