510(k) · Cleared
Recalled · 2008Reprocessed 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 14, 2002 as substantially equivalent to K953768 (Cordis Webster, Inc., 1995) and 1 other predicate after a 373-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Aug 14, 2002
- Review
- 373 days
- Class
- Class II
- Product code
- NLH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K953768 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK953768 Cordis Webster A20 Diagnostic Deflectable Tip CatheterCordis Webster, Inc. · 1995 · Recalled
- This deviceK012523 Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953768 | Cordis Webster A20 Diagnostic Deflectable Tip Catheter | Cordis Webster, Inc. | 1995 | 4 |
| 0 (this device) | K012523 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953768 | Cordis Webster A20 Diagnostic Deflectable Tip CatheterSummary page 1…ClassII, 21 CFR 870.1220 Product Code: DRF Predicate Device(s): The SterilMed reprocessed electrophysiology diagnostic catheter is substantially equivalent to: the A20 (K953768), manufactured by Biosense Webster (formerly known as Cordis Webster), the Bard Dynamic Tip Catheter (K912213), and the Bard Intr… | 1995 |
| Kept off the family tree | K912213 | Bard Dynamic Tip Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…agnostic catheter is substantially equivalent to: the A20 (K953768), manufactured by Biosense Webster (formerly known as Cordis Webster), the Bard Dynamic Tip Catheter (K912213), and the Bard Intracardiac Electrode Catheter manufactured by C.R. Bard Inc., the Stablemapr EP Diagnostic Catheter (K981642), m… | |
| * | K981642 | Stablemapr Steerable Intracardiac CathetersSummary page 1…is Webster), the Bard Dynamic Tip Catheter (K912213), and the Bard Intracardiac Electrode Catheter manufactured by C.R. Bard Inc., the Stablemapr EP Diagnostic Catheter (K981642), manufactured by Medtronic Inc.,-and the original manufacturers’ devices. Device Description: The device consists of a reproces… | 1998 |
| * | — | Bard Intracardiac Electrode Catheter Named without a submission number | |
| * | — | original manufacturers’ devices Named without a submission number |
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 |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0555-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 6 other devices also cite its predicate K953768.
How does its category compare?
All NLH devicesNLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.
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/K012523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012523: 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/K012523
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026