510(k) · Cleared
ClearedReprocessed Electrophysiology Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Sep 16, 2008 as substantially equivalent to K031161 (Biosense Webster, Inc., 2003) and 1 other predicate after a 62-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Sep 16, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002333 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
- 1 generation backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
- This deviceK082023 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008
- Descendant · cites it directly · 0 of its ownK112292 Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K112292Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | 2 |
| −1 | K031161 | Variable Lasso 2515 Circular Mapping Catheter | Biosense Webster, Inc. | 2003 | 2 |
| 0 (this device) | K082023 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | 2008 | — |
| +1 | K112292 | Reprocessed 2515 Nav Variable Electrophysiology Catheter | Stryker Sustainability Solutions | 2011 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031161 | Variable Lasso 2515 Circular Mapping CatheterSummary page 1…Name: Electrode recording catheter or electrode recording probe Predicate Device 510(k) Title Manufacturer K031161 Lasso MT 2515 Variable Circular Biosense Webster, Inc. Mapping Catheter K0023… | 2003 |
| * | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220Summary page 1…Manufacturer K031161 Lasso MT 2515 Variable Circular Biosense Webster, Inc. Mapping Catheter K002333 Lasso TM Deflectable Circular Biosense Webster, Inc. Mapping Catheter Devi… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112292 | Reprocessed 2515 Nav Variable Electrophysiology Catheter | 2011 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K112292 (Stryker Sustainability Solutions, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031161.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082023 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082023: Reprocessed Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082023
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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