510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Electrophysiology Catheter

K012708510(k) TraditionalCleared Aug 13, 2002364-day reviewClass II21 CFR 870.1220Recalls 29

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 Aug 13, 2002 as substantially equivalent to K891908 (C.R. Bard, Inc., 1989) and 20 other predicates after a 364-day review. Its family tree reaches back 1 generation to 1989. 5 later devices descend from it. It has been recalled 29 times.

Decided
Aug 13, 2002
Review
364 days
Class
Class II
Product code
NLH
Recalls
29
Predicates
26

Its longest line of descent runs back 1 generation to K891908 (1989). 21 ancestors in all. 5 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1999: 2 other ancestors1998: 1 other ancestor1997: 2 other ancestors1996: 3 other ancestors1995: 1 other ancestor1994: 4 other ancestors1993: 3 other ancestors1992: 1 other ancestor1991: 1 other ancestor2005: 4 descendants cleared2003: 1 descendant clearedK891908 · Bard (R) Tip Deflecting Electrode Catheter · C.R. Bard, Inc. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 20 other ancestors 1 generation forward: 5 descendants K891908 · Bard (R) Tip Deflecting Electrode Catheter · C.R. Bard, Inc. · 19890
  1. Root · 1 generation backK891908 Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc. · 1989
  2. This deviceK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002
  3. Descendant · cites it directly · 1 of its ownK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
  4. Descendant · cites it directly · 0 of its ownK052414 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005
  5. Descendant · cites it directly · 0 of its ownK052603 Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp. · 2005 · Recalled
  6. Descendant · cites it directly · 0 of its ownK043392 Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2005
  7. Descendant · cites it directly · 0 of its ownK030026 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2003

Most influential descendants

Showing 5 of 5 · See all
  • K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005 · cites it directly1descendant
  • K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005 · cites it directly0descendants
  • K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp. · 2005 · cites it directly0descendants
  • K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2005 · cites it directly0descendants
  • K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K891908Bard (R) Tip Deflecting Electrode CatheterC.R. Bard, Inc.1989—
0 (this device)K012708Electrophysiology CatheterAlliance Medical Corp.2002—
+1K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.2005—
+1K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.2005—
+1K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp.200526
+1K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp.2005—
+1K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199330
199440
199510
199630
199720
199810
199920
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200540
FIG. 1 — Lineage of K012708, 1989–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (26)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K891908Bard (R) Tip Deflecting Electrode Catheter
Summary page 9
…Technologies ~ 1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379…
C.R. Bard, Inc.1989—
Kept off the family treeK904080Bard
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 9
…1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976…
Kept off the family treeK912213Bard
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
Kept off the family treeK921872Bard
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 9
…K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531…
*K971265Viking Diagnostic Electrode Catheter
Summary page 9
…K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167 K98 1642 K992965…
C.R. Bard, Inc.1997—
Kept off the family treeK892265Cordis Webster
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 9
…Technologies ~ 1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108…
*K953663Cordis Webster T20 Diagnostic Deflectable Tip Catheter
Summary page 9
…1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109…
Cordis Webster, Inc.1996—
Kept off the family treeK953678FDA’s K953678 is Sterimed Sterization Wrapper (Non-Sterile)
Our reading of the summary gave K953678, FDA’s number for Sterimed Sterization Wrapper (Non-Sterile) (Customed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cordis Webster”. Kept off the family tree.
Summary page 9
…K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163…
Customed, Inc.1995—
*K955817Coridis Webster Deflectable Braided-Tip Electrode Catheter
Summary page 9
…K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167…
Cordis Webster, Inc.1996—
*K991531Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078
Summary page 9
…KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167 K98 1642 K992965 K940 168…
Cordis Webster, Inc.1999—
*K992965Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085
Summary page 9
…K924 163 K964272 K97 1265 K991531 K940 167 K98 1642 K992965 K940 168 KO02333 KO03452 *The CelsidCelsiu…
Cordis Webster, Inc.1999—
*K002333Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220Biosense Webster, Inc.20002
*K914278Daig Electrophysiology Catheter W/Infusion Lumen
Summary page 9
…Technologies ~ 1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951…
Daig Corp.1992—
*K942379Daig Diagnostic Electrophysiology Catheter
Summary page 9
…1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953…
Daig Corp.1994—
*K913375Torque Tube Steerocath (TM)
Summary page 9
…Technologies ~ 1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22…
Ep Technologies, Inc.1991—
*K924108Tracfinder II
Summary page 9
…1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K92187…
Ep Technologies, Inc.1993—
*K924109Steerocath II
Summary page 9
…K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 12…
Ep Technologies, Inc.1993—
*K924163Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec
Summary page 9
…K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167 K98 1642…
Boston Scientific Corp19931
*K940167Diagnostic I Catheter
Summary page 9
…K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167 K98 1642 K992965 K940 168 KO02333…
Ep Technologies, Inc.1994—
*K940168Diagnostic II Catheter
Summary page 9
…K964272 K97 1265 K991531 K940 167 K98 1642 K992965 K940 168 KO02333 KO03452 *The CelsidCelsiusII diagnostic catheters were approv…
Ep Technologies, Inc.1994—
*K003452Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DEp Technologies, Inc.2000—
*K931794Marinr Series EP Diagnostic Catheters
Summary page 9
…1 Medtronic K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678…
Medtronic Cardiorhythm1994—
*K951347Marinr Series EP Diagnosti Catheters
Summary page 9
…K89 1908 K892265 K9 14278 K9 13375 K93 1794 K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17…
Medtronic Cardiorhythm1995—
*K953185Platinum Series EP Diagnostic Catheters
Summary page 9
…K904080 K953663 K942379 K924 108 K951347 K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531…
Medtronic Cardiorhythm1996—
*K964272Performr Series EP Diagnostic Catheters
Summary page 9
…K9 I22 13 K953678 KO02976 K924 109 K953 185 K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167 K98 1642 K992965…
Medtronic Cardiorhythm1997—
*K981642Stablemapr Steerable Intracardiac Catheters
Summary page 9
…K921872 K9558 17 K924 163 K964272 K97 1265 K991531 K940 167 K98 1642 K992965 K940 168 KO02333…
Medtronic Cardiorhythm1998—

Also cleared against K891908: 4 other devices →

What descends from it? (5)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.20051
K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.20050
K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp.20050
K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp.20050
K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 10, 2026Class IIZ-2192-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2196-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2189-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2191-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2185-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2182-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2198-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2195-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2193-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2194-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2183-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2197-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2177-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2186-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2187-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2176-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2175-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2178-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2179-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2181-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2199-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2184-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2180-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2174-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2190-2026Process controlIncomplete seals on sterile product
Apr 10, 2026Class IIZ-2188-2026Process controlIncomplete seals on sterile product
Oct 6, 2016Class IIZ-0380-2017Under Investigation by firmThe EP Catheters may be mislabeled for French size during reprocessing.
Apr 28, 2016Class IIZ-1708-2016Under Investigation by firmMislabeled for size
Oct 18, 2013Class IIZ-0340-2014Process controlStryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

The 5 latest of 29 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 21 ancestors have a recall of any class.
  • Of its descendants, K043393 (Alliance Medical Corp., 2005) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K891908.

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 EP catheters are indicated for temporary intracardiac seasing, recording, stimulation, and electrophysiological mapping of cardiac structures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K891908

4 other devices cite the same predicate.

  • K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC · 2021
  • K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC · 2016
  • K030187Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 200328 recalls
  • K955847Gyro Tip EP CatheterCardiac Assist Devices, Inc. · 1997

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/K012708 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012708: Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012708

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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