510(k) · Cleared
Recalled · Class II · 2024Reprocessed 2515 Nav Variable Electrophysiology Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Oct 21, 2011 as substantially equivalent to K081258 (Biosense Webster, Inc., 2009) and 2 other predicates after a 72-day review. Its family tree reaches back 3 generations to 2000. It has been recalled 5 times.
- Decided
- Oct 21, 2011
- Review
- 72 days
- Class
- Class II
- Product code
- NLH
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002333 (2000). 5 ancestors in all, the oldest K954390 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
- 2 generations backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
- 1 generation backK082023 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008
- This deviceK112292 Reprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | 2 |
| −2 | K031161 | Variable Lasso 2515 Circular Mapping Catheter | Biosense Webster, Inc. | 2003 | 2 |
| −1 | K082023 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | 2008 | — |
| 0 (this device) | K112292 | Reprocessed 2515 Nav Variable Electrophysiology Catheter | Stryker Sustainability Solutions | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Summary page 1…Name: Electrode recording catheter or electrode recording probe Predicate Device 510(k) Title Manufacturer K081258 Lasso M 2515 NAV Variable Biosense Webster, Inc. Catheter, D-1290-01 &… | 2009 |
| * | K082023 | Reprocessed Electrophysiology CathetersSummary page 1…Manufacturer K081258 Lasso M 2515 NAV Variable Biosense Webster, Inc. Catheter, D-1290-01 & D-1290-02 K082023 Reprocessed Electrophysiology Ascent Healthcare Catheters… | 2008 |
| * | K031161 | Variable Lasso 2515 Circular Mapping CatheterSummary page 1…-02 K082023 Reprocessed Electrophysiology Ascent Healthcare Catheters Solutions K031 161 LaSSoTM 2515 Variable Circular Biosense Webster, Inc. Mapping Catheter Devi… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2024 | Class II | Z-2268-2024 | Process control | Diagnostic electrophysiology (EP) catheters do not meet testing requirements. |
| Dec 17, 2018 | Class II | Z-0766-2019 | Process change control | Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP… |
| Aug 23, 2018 | Class II | Z-0467-2019 | Under Investigation by firm | Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing. |
| Jan 2, 2018 | Class II | Z-0916-2018 | Device Design | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. |
| Jan 2, 2018 | Class II | Z-0917-2018 | Device Design | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K081258.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed 2515 NAV Variable EP 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.
https://510kreport.com/device/K112292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112292: Reprocessed 2515 Nav Variable Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112292
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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