510(k) · Cleared
Recalled · Class II · 2013Electrophysiology Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · NLH Catheter, Recording, Electrode, Reprocessed
Cleared on Aug 8, 2003 as substantially equivalent to K992965 (Cordis Webster, Inc., 1999) after a 207-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Aug 8, 2003
- Review
- 207 days
- Class
- Class II
- Product code
- NLH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992965 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992965 Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085Cordis Webster, Inc. · 1999
- This deviceK030109 Electrophysiology CatheterAlliance Medical Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992965 | Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085 | Cordis Webster, Inc. | 1999 | — |
| 0 (this device) | K030109 | Electrophysiology Catheter | Alliance Medical Corp. | 2003 | — |
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 |
|---|---|---|---|
| * | K992965 | Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085Summary page 6…er or Electrode Recording Catheter Classification Name: Electrode Recording Catheter Predicate device(s): K992965 Cordis Webster Fixed Curve Catheters, Models D-11 Device description: Diagnostic electrophysiology (EP) catheters are spec… | 1999 |
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 |
|---|---|---|---|---|
| Oct 18, 2013 | Class II | Z-0340-2014 | Process control | Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K992965.
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?
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Indications for Use: Reprocessed Electrophysiology (EP) Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
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/K030109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030109: 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/K030109
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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