510(k) · Cleared
ClearedReprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Jun 23, 2016 as substantially equivalent to K113213 (Biosense Webster, Inc., 2011) after a 253-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Jun 23, 2016
- Review
- 253 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002333 (2000). 6 ancestors in all, the oldest K954390 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
- 4 generations backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
- 3 generations backK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
- 2 generations backK093376 Lasso Nav CatheterBiosense Webster, Inc. · 2010
- 1 generation backK113213 Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter…Biosense Webster, Inc. · 2011 · Recalled
- This deviceK153006 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable…Sterilmed, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | 2 |
| −4 | K031161 | Variable Lasso 2515 Circular Mapping Catheter | Biosense Webster, Inc. | 2003 | 2 |
| −3 | 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 | — |
| −1 | K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From… | Biosense Webster, Inc. | 2011 | 1 |
| 0 (this device) | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology… | Sterilmed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 NLH? 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 NLH device
- #1 K252405 Medline ReNewal Reprocessed Boston Scientific…score 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Summary page 5…Panel: Cardiovascular PREDICATE DEVICE Lasso 2515 NAV eco Variable Catheter, Lasso NAV eco Catheter – K113213 SUBSTANTIALLY EQUIVALENT TO: The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) C… | 2011 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113213.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NLH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLH
165in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLH
28so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NLH
66in 2025
MAUDE reports naming product code NLH, 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 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 120 | 0 | 8 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 6 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 11 | 133 | 3 | 25 |
| 2017 | 4 | 138 | 0 | 11 |
| 2018 | 4 | 122 | 4 | 21 |
| 2019 | 4 | 195 | 0 | 38 |
| 2020 | 2 | — | 0 | 28 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 30 |
| 2024 | 6 | 165 | 0 | 47 |
| 2025 | 2 | — | 0 | 66 |
| 2026 | 0 | — | 28 (1) | — |
What is it indicated for?
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheters are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (Nav) capabilities provide location information when used with compatible Carto® 3 EP Navigation Systems. (These catheters are not compatible with Carto® 3 EP Navigation Systems prior to version 2.3.)
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/K153006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153006: Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153006
Report an extraction error
Are you the manufacturer?
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