510(k) Report

510(k) · Cleared

Cleared

Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02

K081258510(k) TraditionalCleared Jan 6, 2009249-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

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

Cleared on Jan 6, 2009 as substantially equivalent to K031161 (Biosense Webster, Inc., 2003) and 1 other predicate after a 249-day review. Its family tree reaches back 2 generations to 2000. 7 later devices descend from it.

Decided
Jan 6, 2009
Review
249 days
Class
Class II
Product code
DRF
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K002333 (2000). 3 ancestors in all, the oldest K954390 (1995). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2011: 2 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2013: 1 descendant cleared2022: 1 descendant clearedK002333 · Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 · Biosense Webster, Inc. · 2000 · recalledK031161 · Variable Lasso 2515 Circular Mapping Catheter · Biosense Webster, Inc. · 2003 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants K031161 · Variable Lasso 2515 Circular Mapping Catheter · Biosense Webster, Inc. · 2003 · recalledK002333 · Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 · Biosense Webster, Inc. · 2000 · recalled0
  1. Root · 2 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
  2. 1 generation backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
  3. This deviceK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
  4. Descendant · cites it directly · 5 of its ownK093376 Lasso Nav CatheterBiosense Webster, Inc. · 2010
  5. Descendant · cites it directly · 4 of its ownK113213 Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter…Biosense Webster, Inc. · 2011 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK211327 Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…CathRx, Ltd. · 2022
  7. Descendant · 2 generations on · 0 of its ownK153006 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable…Sterilmed, Inc. · 2016
  8. Descendant · cites it directly · 0 of its ownK153153 Reprocessed Electrophysiology CatheterInnovative Health, LLC · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22013: 12016: 22022: 1
2010high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K093376Lasso Nav CatheterBiosense Webster, Inc. · 2010 · cites it directly5descendants
  • K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Biosense Webster, Inc. · 2011 · cites it directly4descendants
  • K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…CathRx, Ltd. · 2022 · 2 generations on0descendants
  • K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc. · 2016 · 2 generations on0descendants
  • K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002333Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220Biosense Webster, Inc.20002
−1K031161Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc.20032
0 (this device)K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc.2009—
+1K093376Lasso Nav CatheterBiosense Webster, Inc.2010—
+1K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From…Biosense Webster, Inc.20111
+2K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…CathRx, Ltd.2022—
+2K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology…Sterilmed, Inc.2016—
+1K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201310
201620
202210
FIG. 1 — Lineage of K081258, 2000–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K031161Variable Lasso 2515 Circular Mapping Catheter
Summary page 1
…(per 21 CFR 870.1220, Product Code DRF) Predicate Devices: 1. Variable Lasso 2515 Circular MappingCatheter [5 10(k) K031161] 2. Star Diagnostic Catheter ([5 10(k) K954390] (later renamed NaviSta…
Biosense Webster, Inc.20032
*K954390Cordis Wester Star Catheter
Summary page 1
…1. Variable Lasso 2515 Circular MappingCatheter [5 10(k) K031161] 2. Star Diagnostic Catheter ([5 10(k) K954390] (later renamed NaviStar Diagnostic Catheter) Manufacturer: Biosense Webster, Inc.…
Cordis Webster, Inc.1995—

Also cleared against K031161: 2 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K093376Lasso Nav CatheterBiosense Webster, Inc.20105
K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Biosense Webster, Inc.20114
K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC20160
K112292Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions20110

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?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K093376 (Biosense Webster, Inc., 2010) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K031161.

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. 2009, this device’s year, is highlighted.

FDA decisions per year · DRF

3in 2025

2007: 22008: 22009: 72010: 52011: 32012: 12013: 22014: 12015: 32016: 82017: 72018: 12019: 102020: 42021: 122022: 82023: 52024: 42025: 32026 (partial year): 2
2007high 12 (2021) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRF

45in 2023

2009: 243 days median2010: 65 days median2011: 190 days median2015: 29 days median2016: 175 days median2019: 163 days median2021: 124 days median2022: 283 days median2023: 45 days median
2007high 283 (2022) · low 29 (2015)2026

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

Recalls per year · DRF

1in 2015

2007: 22008: 42011: 62014: 22015: 1
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

2007: 1202008: 1762009: 1222010: 1302011: 2452012: 4022013: 3102014: 3492015: 3272016: 3832017: 4582018: 7232019: 6692020: 6512021: 6252022: 6132023: 6852024: 6232025: 508
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—2120
20082—4176
200972430122
20105650130
201131906245
20121—0402
20132—0310
20141—2349
20153291327
201681750383
20177—0458
20181—0723
2019101630669
20204—0651
2021121240625
202282830613
20235450685
20244—0623
20253—0508
20262—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 or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.

Indications for use as stated in the FDA summary.

Also cleared against K031161

2 other devices cite the same predicate.

  • K112292Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions · 20115 recalls
  • K082023Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008

More from Biosense Webster, Inc.

638 FDA decisions under this applicant name. See the company

  • P030031/S146EZ Steer Thermocool Nav BI-Directional Electrophysiology Catheter; Thermocool Smarttouch BI-Directional…Biosense Webster, Inc. · 2026
  • P240006/S020Varipulse BI-Directional CatheterBiosense Webster, Inc. · 2026
  • P040036/S101Thermocool Smarttouch BI-Directional Navigation Catheter; Thermocool Smarttouch Uni-Directional Navigation…Biosense Webster, Inc. · 2026
  • P210027/S019Qdot Micro BI-Directional Navigation Catheter; Qdot Micro Uni-Directional Navigation CatheterBiosense Webster, Inc. · 2026
  • P210027/S018QDOT MICRO™ SystemBiosense Webster, Inc. · 2026

Recent decisions in DRF

The DRF category page

  • K262068Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)CathRx, Ltd. · 2026
  • K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. · 2026
  • K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc. · 2025
  • K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation · 2025
  • P990025/S074NAVISTAR Electrophysiology CatheterBiosense Webster, Inc. · 2025

https://510kreport.com/device/K081258 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081258

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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