510(k) · Cleared

Cleared

Rhyder Diagnostic Catheter

K962307510(k) TraditionalCleared Sep 17, 199692-day reviewClass II21 CFR 870.1220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fidus Medical Technology Corp. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Sep 17, 1996 as substantially equivalent to K900452 (Ep Technologies, Inc., 1990) and 2 other predicates after a 92-day review. Its family tree reaches back 1 generation to 1989.

Decided: Sep 17, 1996
Review: 92 days
Class: Class II
Product code: DRF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K894500 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK894500 Daig Electrophysiology CatheterDaig Corp. · 1989 · Recalled
This deviceK962307 Rhyder Diagnostic CatheterFidus Medical Technology Corp. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894500	Daig Electrophysiology Catheter	Daig Corp.	1989	1
0 (this device)	K962307	Rhyder Diagnostic Catheter	Fidus Medical Technology Corp.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0

FIG. 1 — Lineage of K962307, 1989–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K900452	Quattro Catheter Summary page 1 …this catheter obviate the need to insert a separate catheter for stimulation in MAP studies. PREDICATE DEVICES * EP Technologies, Inc. Franz™ Combination Map Catheter (K900452) * Daig Response™ Electrophysiology Catheter (K894500, K942379) Rhyder Diagnostic Catheter 510(k) 10 TESTING in…	Ep Technologies, Inc.	1990	—
*	K894500	Daig Electrophysiology Catheter Summary page 1 …theter for stimulation in MAP studies. PREDICATE DEVICES * EP Technologies, Inc. Franz™ Combination Map Catheter (K900452) * Daig Response™ Electrophysiology Catheter (K894500, K942379) Rhyder Diagnostic Catheter 510(k) 10 TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION The…	Daig Corp.	1989	1
*	K942379	Daig Diagnostic Electrophysiology Catheter Summary page 1 …r stimulation in MAP studies. PREDICATE DEVICES * EP Technologies, Inc. Franz™ Combination Map Catheter (K900452) * Daig Response™ Electrophysiology Catheter (K894500, K942379) Rhyder Diagnostic Catheter 510(k) 10 TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION The results o…	Daig Corp.	1994	—

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 3 ancestors has a recall of any class.

How does its category compare?

All DRF devices

DRF 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

2007high 12 (2021) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRF

45in 2023

2007high 283 (2022) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRF

1in 2015

2007high 6 (2011) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRF

508in 2025

2007high 723 (2018) · low 120 (2007)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 Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.

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/K962307 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962307: Rhyder Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962307

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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