510(k) · Cleared
ClearedReprocessed Electrophysiology Catheters
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 Mar 25, 2005 as substantially equivalent to K894500 (Daig Corp., 1989) and 2 other predicates after a 105-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Mar 25, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K891908 (1989). 23 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891908 | Bard (R) Tip Deflecting Electrode Catheter | C.R. Bard, Inc. | 1989 | — |
| −1 | K012708 | Electrophysiology Catheter | Alliance Medical Corp. | 2002 | 29 |
| 0 (this device) | K043392 | Reprocessed Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 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 |
|---|---|---|---|
| * | K894500 | Daig Electrophysiology CatheterSummary page 1…Classification Name: Electrode Recording Catheter Predicate device: KNumber Device Description K894500 Daig Electrophysiology Catheter K942379 Daig Diagnostic Electrophysiology Catheter K012708 Repr… | 1989 |
| * | K942379 | Daig Diagnostic Electrophysiology CatheterSummary page 1…rding Catheter Predicate device: KNumber Device Description K894500 Daig Electrophysiology Catheter K942379 Daig Diagnostic Electrophysiology Catheter K012708 Reprocessed Electrophysiology Catheters Device descriptio… | 1994 |
| * | K012708 | Electrophysiology CatheterSummary page 1…Device Description K894500 Daig Electrophysiology Catheter K942379 Daig Diagnostic Electrophysiology Catheter K012708 Reprocessed Electrophysiology Catheters Device description: Diagnostic electrophysiology (EP) catheters awe specieall… | 2002 |
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 16 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- 4 of the 23 ancestors have a recall of any class.
- 6 other devices also cite its predicate K894500.
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 as stated in the FDA summary.
https://510kreport.com/device/K043392 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043392: Reprocessed Electrophysiology Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043392
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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