510(k) · Cleared

Recalled · 2008

Variable Lasso 2515 Circular Mapping Catheter

K031161510(k) SpecialCleared Jul 22, 200399-day reviewClass II21 CFR 870.1220Recalls 2

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

Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Jul 22, 2003 as substantially equivalent to K002333 (Biosense Webster, Inc., 2000) after a 99-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it. It has been recalled 2 times.

Decided: Jul 22, 2003
Review: 99 days
Class: Class II
Product code: DRF
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K002333 (2000). 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
This deviceK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003
Descendant · cites it directly · 7 of its ownK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
Descendant · 2 generations on · 5 of its ownK093376 Lasso Nav CatheterBiosense Webster, Inc. · 2010
Descendant · 2 generations on · 4 of its ownK113213 Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter…Biosense Webster, Inc. · 2011 · Recalled
Descendant · cites it directly · 1 of its ownK082023 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008
Descendant · 3 generations on · 0 of its ownK211327 Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…CathRx, Ltd. · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all

K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009 · cites it directly7descendants
K093376Lasso Nav CatheterBiosense Webster, Inc. · 2010 · 2 generations on5descendants
K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Biosense Webster, Inc. · 2011 · 2 generations on4descendants
K082023Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008 · cites it directly1descendant
K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…CathRx, Ltd. · 2022 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002333	Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220	Biosense Webster, Inc.	2000	2
0 (this device)	K031161	Variable Lasso 2515 Circular Mapping Catheter	Biosense Webster, Inc.	2003	—
+1	K081258	Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02	Biosense Webster, Inc.	2009	—
+2	K093376	Lasso Nav Catheter	Biosense Webster, Inc.	2010	—
+2	K113213	Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From…	Biosense Webster, Inc.	2011	1
+1	K082023	Reprocessed Electrophysiology Catheters	Ascent Healthcare Solutions	2008	—
+3	K211327	Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…	CathRx, Ltd.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2013	1	0
2016	2	0
2022	1	0

FIG. 1 — Lineage of K031161, 2000–2022Source: 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 13.6 · 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? (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	Applicant	Decided	Recalls
*	K002333	Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220	Biosense Webster, Inc.	2000	2

Also cleared against K002333: 5 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K081258	Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02	Biosense Webster, Inc.	2009	7
K082023	Reprocessed Electrophysiology Catheters	Ascent Healthcare Solutions	2008	1
K112292	Reprocessed 2515 Nav Variable Electrophysiology Catheter	Stryker Sustainability Solutions	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 25, 2008	Not classified	Z-1704-2008	Device Design	This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable…
Mar 25, 2008	Not classified	Z-1703-2008	Device Design	This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K081258 (Biosense Webster, Inc., 2009) has gone furthest, with 7 descendants of its own.
5 other devices also cite its predicate K002333.

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 catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only. The LASSO25 15 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031161 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031161: Variable Lasso 2515 Circular Mapping Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031161

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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