510(k) · Cleared

Cleared

Gyro Tip EP Catheter

K955847510(k) TraditionalCleared Jan 29, 1997400-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

Cardiac Assist Devices, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Jan 29, 1997 as substantially equivalent to K891908 (C.R. Bard, Inc., 1989) and 1 other predicate after a 400-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Jan 29, 1997
Review: 400 days
Class: Class II
Product code: DRF
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K891908 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK891908 Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc. · 1989
This deviceK955847 Gyro Tip EP CatheterCardiac Assist Devices, Inc. · 1997
Descendant · cites it directly · 0 of its ownK012520 Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20ECardiac Assist Devices, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all

K012520Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20ECardiac Assist Devices, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891908	Bard (R) Tip Deflecting Electrode Catheter	C.R. Bard, Inc.	1989	—
0 (this device)	K955847	Gyro Tip EP Catheter	Cardiac Assist Devices, Inc.	1997	—
+1	K012520	Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20E	Cardiac Assist Devices, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K955847, 1989–2002Source: 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K912213	Bard Dynamic Tip Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …cations, Cautions, Description, Warnings and Precautions. 6. Substantial Equivalence: The Gyro Tip EP Catheter is substantially equivalent to Bard Dynamic Tip Catheter (K912213), Bard Tip Deflecting Catheter (K904080), Bard Tip Deflecting Electrode Catheter (K891908), and Steerocath (K900765). Section 4 o…
Kept off the family tree	K904080	Bard Tip Deflecting Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …and Precautions. 6. Substantial Equivalence: The Gyro Tip EP Catheter is substantially equivalent to Bard Dynamic Tip Catheter (K912213), Bard Tip Deflecting Catheter (K904080), Bard Tip Deflecting Electrode Catheter (K891908), and Steerocath (K900765). Section 4 of this document contains a detailed stat…
*	K891908	Bard (R) Tip Deflecting Electrode Catheter Summary page 2 …Gyro Tip EP Catheter is substantially equivalent to Bard Dynamic Tip Catheter (K912213), Bard Tip Deflecting Catheter (K904080), Bard Tip Deflecting Electrode Catheter (K891908), and Steerocath (K900765). Section 4 of this document contains a detailed statement of substantial equivalence. 7. Section 1 (E…	C.R. Bard, Inc.	1989	—
*	K900765	Steerocath (TM) Summary page 2 …ubstantially equivalent to Bard Dynamic Tip Catheter (K912213), Bard Tip Deflecting Catheter (K904080), Bard Tip Deflecting Electrode Catheter (K891908), and Steerocath (K900765). Section 4 of this document contains a detailed statement of substantial equivalence. 7. Section 1 (Executive Summary) of this…	Ep Technologies, Inc.	1990	—

Also cleared against K891908: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012520	Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20E	Cardiac Assist Devices, Inc.	2002	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, K012520 (Cardiac Assist Devices, Inc., 2002) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K891908.

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?

Monitor and record intra-cardiac electrical activities

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/K955847 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955847: Gyro Tip EP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955847

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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