510(k) · Cleared
ClearedPadtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Apr 18, 2003 as substantially equivalent to K961924 (Irvine Biomedical, Inc., 1997) and 1 other predicate after a 350-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 18, 2003
- Review
- 350 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946333 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946333 Ibi-1000(TM) Electrophysiology CathterIrvine Biomedical, Inc. · 1995
- This deviceK021421 Padtac Electrophysiology Recording Catheters, Junction Cable…Tz Medical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946333 | Ibi-1000(TM) Electrophysiology Cathter | Irvine Biomedical, Inc. | 1995 | — |
| 0 (this device) | K021421 | Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable | Tz Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K961924 | Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 1…FORMATION SUMMARY A. Predicate Device IBI 1100 Electrophysiology Catheter System K961924 IBI 1000 Electrophysiology Catheter System… | 1997 |
| * | K946333 | Ibi-1000(TM) Electrophysiology CathterSummary page 1…K961924 IBI 1000 Electrophysiology Catheter System K946333 C. Device Description The PadTac Electrophysiology catheters ;are… | 1995 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 11 other devices also cite its predicate K961924.
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?
The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021421: Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021421
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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