510(k) · Cleared

Cleared

Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569

K010471510(k) SpecialCleared Jun 6, 2001106-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

Irvine Biomedical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Jun 6, 2001 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it.

Decided: Jun 6, 2001
Review: 106 days
Class: Class II
Product code: DRF
Recalls: None
Predicates: 0

41 later devices descend from it, 4 citing it directly.

This deviceK010471 Afocus Electropysiology Catheter System, Models 81550, 81567, 81568…Irvine Biomedical, Inc. · 2001
Descendant · cites it directly · 40 of its ownK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
Descendant · 2 generations on · 25 of its ownK160335 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni…St Jude Medical · 2016
Descendant · 3 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
Descendant · 3 generations on · 18 of its ownK192037 Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019
Descendant · 3 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2004high 6 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 41 · See all

K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterIrvine Biomedical, Inc. · 2004 · cites it directly40descendants
K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…St Jude Medical · 2016 · 2 generations on25descendants
K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 3 generations on21descendants
K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019 · 3 generations on18descendants
K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 3 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010471	Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569	Irvine Biomedical, Inc.	2001	—
+1	K042775	Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…	Irvine Biomedical, Inc.	2004	—
+2	K160335	Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor…	St Jude Medical	2016	—
+3	K172393	Advisor HD Grid Mapping Catheter, Sensor Enabled	St. Jude Medical, Inc.	2018	—
+3	K192037	Advisor VL Circular Mapping Catheter, Sensor Enabled	Abbott Medical	2019	—
+3	K202066	EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled…	Abbott Medical	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	3	0
2007	1	0
2008	2	0
2009	2	0
2010	2	0
2011	1	0
2016	3	0
2018	2	0
2019	2	0
2020	3	0
2021	3	0
2022	2	0
2023	1	0
2024	2	0
2025	6	0
2026	5	0

FIG. 1 — Lineage of K010471, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (41)

See all 41

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042775	Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter	Irvine Biomedical, Inc.	2004	40
K081329	Reprocessed Electrophysiology Catheters	Ascent Healthcare Solutions	2008	1
K112232	Reprocessed Electrophysiology Catheters	Stryker Sustainability Solutions	2011	0
K101789	Reprocessed Electrophysiology Diagnostic Catheters	Sterilmed, Inc.	2010	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?

Of its descendants, K042775 (Irvine Biomedical, Inc., 2004) has gone furthest, with 40 descendants of its own.

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	—

https://510kreport.com/device/K010471 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010471: Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010471

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026