510(k) · Cleared
ClearedReprocessed EP Technologies 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 23, 2005 as substantially equivalent to K924109 (Ep Technologies, Inc., 1993) and 4 other predicates after a 103-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Mar 23, 2005
- Review
- 103 days
- Class
- Class II
- Product code
- NLH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K891908 (1989). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK891908 Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc. · 1989
- 1 generation backK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002 · Recalled
- This deviceK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
- Descendant · cites it directly · 0 of its ownK052414 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005 · cites it directly0descendants
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) | K043393 | Reprocessed EP Technologies Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
| +1 | K052414 | Reprocessed Electrophysiology Catheter | Alliance Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K924109 | Steerocath IISummary page 1…physiology Catheter or Electrode Recording Catheter Classification Name: Electrode Recording Catheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Ca… | 1993 |
| * | K924163 | Explorer/360-Polaris-L.E./Jackman Coron Sinus ElecSummary page 1…Electrode Recording Catheter Classification Name: Electrode Recording Catheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter KO012708 Reproce… | 1993 |
| * | K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DSummary page 1…g Catheter Classification Name: Electrode Recording Catheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter KO012708 Reprocessed Electrophysiology Catheter… | 2000 |
| * | K954651 | Electrode Recording CatheterSummary page 1…Classification Name: Electrode Recording Catheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter KO012708 Reprocessed Electrophysiology Catheters Device description: D… | 1996 |
| * | K012708 | Electrophysiology CatheterSummary page 1…ter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter KO012708 Reprocessed Electrophysiology Catheters Device description: Diagnostic electrophysiology (EP) catheters are spe… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052414 | Reprocessed Electrophysiology Catheter | 2005 | 0 |
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.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K052414 (Alliance Medical Corp., 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K924109.
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 diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043393: Reprocessed EP Technologies 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/K043393
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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