510(k) · Cleared
ClearedReprocessed Electrophysiology Diagnostic Catheters
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 Aug 6, 2012 as substantially equivalent to K101345 (Biosense Webster, Inc., 2010) after a 112-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Aug 6, 2012
- Review
- 112 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K050877 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK050877 Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc. · 2005
- 2 generations backK090898 Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01…Biosense Webster, Inc. · 2009 · Recalled
- 1 generation backK101345 Webster CS Catheter with EZ Steer Technology, Webster CS Catheter…Biosense Webster, Inc. · 2010 · Recalled
- This deviceK121158 Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050877 | Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR | Biosense Webster, Inc. | 2005 | — |
| −2 | K090898 | Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS… | Biosense Webster, Inc. | 2009 | 1 |
| −1 | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ… | Biosense Webster, Inc. | 2010 | 1 |
| 0 (this device) | K121158 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K101345 | Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer…Summary page 1…ctive, and substantially equivalent to the predicate devices, Biosense Webster Coronary Sinus Catheters with EZ Steer Technology (K101345), as described in this preniarket notification submission.… | 2010 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 8 other devices also cite its predicate K101345.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121158: Reprocessed Electrophysiology Diagnostic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121158
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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