510(k) Report

510(k) · Cleared

Cleared

Reprocessed Electrophysiology Catheter

K052414510(k) TraditionalCleared Nov 16, 200575-day reviewClass II21 CFR 870.1220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alliance Medical Corp. · NLH Catheter, Recording, Electrode, Reprocessed

Cleared on Nov 16, 2005 as substantially equivalent to K924109 (Ep Technologies, Inc., 1993) and 5 other predicates after a 75-day review. Its family tree reaches back 3 generations to 1989.

Decided
Nov 16, 2005
Review
75 days
Class
Class II
Product code
NLH
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K891908 (1989). 24 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestors1996: 4 other ancestors1993: 3 other ancestors1999: 2 other ancestors1998: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1994: 4 other ancestors1992: 1 other ancestor1991: 1 other ancestorK891908 · Bard (R) Tip Deflecting Electrode Catheter · C.R. Bard, Inc. · 1989K012708 · Electrophysiology Catheter · Alliance Medical Corp. · 2002 · recalledK043393 · Reprocessed EP Technologies Electrophysiology Catheters · Alliance Medical Corp. · 200519851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 17 other ancestors K043393 · Reprocessed EP Technologies Electrophysiology Catheters · Alliance Medical Corp. · 2005K012708 · Electrophysiology Catheter · Alliance Medical Corp. · 2002 · recalledK891908 · Bard (R) Tip Deflecting Electrode Catheter · C.R. Bard, Inc. · 19890
  1. Root · 3 generations backK891908 Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc. · 1989
  2. 2 generations backK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002 · Recalled
  3. 1 generation backK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
  4. This deviceK052414 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K891908Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc.1989—
−2K012708Electrophysiology CatheterAlliance Medical Corp.200229
−1K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.2005—
0 (this device)K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199330
199440
199510
199640
199720
199810
199920
200020
FIG. 1 — Lineage of K052414, 1989–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252405 Medline ReNewal Reprocessed Boston Scientific…score 10.4 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K924109Steerocath II
Summary 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…
Ep Technologies, Inc.1993—
*K924163Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec
Summary 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 K012708 Reproce…
Boston Scientific Corp19931
*K003452Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D
Summary page 1
…ng Catheter Classification Name: Electrode Recording Catheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter K012708 Reprocessed Electrophysiology Catheter…
Ep Technologies, Inc.2000—
*K954651Electrode Recording Catheter
Summary page 1
…Classification Name: Electrode Recording Catheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter K012708 Reprocessed Electrophysiology Catheters K043393 Reproces…
Boston Scientific Corp1996—
*K012708Electrophysiology Catheter
Summary page 1
…atheter Predicate device: K924109 Steerocath Dx K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter K012708 Reprocessed Electrophysiology Catheters K043393 Reprocessed EP Technologies Electrophysiology Catheters D…
Alliance Medical Corp.200229
*K043393Reprocessed EP Technologies Electrophysiology Catheters
Summary page 1
…K924163 Polaris LE K003452 Polaris X K954651 Electrode Recording Catheter K012708 Reprocessed Electrophysiology Catheters K043393 Reprocessed EP Technologies Electrophysiology Catheters Device description: Diagnostic Electrophysiology (EP) Ca…
Alliance Medical Corp.2005—

Also cleared against K924109: 2 other devices →

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 2.6 years on median.
  • 3 of the 24 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K924109.

How does its category compare?

All NLH devices

NLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NLH

2in 2025

2008: 22009: 12010: 32011: 22012: 12015: 12016: 112017: 42018: 42019: 42020: 22021: 22022: 12023: 12024: 62025: 2
2007high 11 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NLH

165in 2024

2010: 120 days median2016: 133 days median2017: 138 days median2018: 122 days median2019: 195 days median2024: 165 days median
2007high 195 (2019) · low 120 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NLH

28so far in 2026, the most since 2007

2008: 12013: 12016: 32018: 42026 (partial year): 28, 1 Class I
2007high 28 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NLH

66in 2025

2007: 12009: 12010: 82011: 102012: 92013: 62014: 172015: 342016: 252017: 112018: 212019: 382020: 282021: 552022: 122023: 302024: 472025: 66
2007high 66 (2025) · low 0 (2008)2025

MAUDE reports naming product code NLH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20082—10
20091—01
2010312008
20112—010
20121—09
20130—16
20140—017
20151—034
201611133325
20174138011
20184122421
20194195038
20202—028
20212—055
20221—012
20231—030
20246165047
20252—066
20260—28 (1)—

What is it indicated for?

Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Indications for use as stated in the FDA summary.

Also cleared against K924109

2 other devices cite the same predicate.

  • K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
  • K012708Electrophysiology CatheterAlliance Medical Corp. · 200229 recalls

More from Alliance Medical Corp.

36 FDA decisions under this applicant name. See the company

  • K060648Reprocessed Phacoemulsification TipsAlliance Medical Corp. · 2007
  • K061045Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2006
  • K060049Reprocessed Compression SleevesAlliance Medical Corp. · 2006
  • K060091Alliance Medical Corporation Reprocessed Compression SleevesAlliance Medical Corp. · 2006
  • K053316Reprocessed Compression SleevesAlliance Medical Corp. · 2006

Recent decisions in NLH

The NLH category page

  • K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. · 2025
  • K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. · 2025
  • K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. · 20242 Class I recalls
  • K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 20242 Class I recalls
  • K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc. · 2024

https://510kreport.com/device/K052414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052414: Reprocessed 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/K052414

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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