510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Reprocessed Electrophysiology Catheter

K030187510(k) TraditionalCleared Sep 24, 2003246-day reviewClass II21 CFR 870.1220Recalls 28

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

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

Cleared on Sep 24, 2003 as substantially equivalent to K891908 (C.R. Bard, Inc., 1989) and 3 other predicates after a 246-day review. Its family tree reaches back 1 generation to 1987. It has been recalled 28 times.

Decided
Sep 24, 2003
Review
246 days
Class
Class II
Product code
NLH
Recalls
28
Predicates
4

Its longest line of descent runs back 1 generation to K874208 (1987). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestorK874208 · Bard Octapolar Electrode Catheter · C.R. Bard, Inc. · 198719851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors K874208 · Bard Octapolar Electrode Catheter · C.R. Bard, Inc. · 19870
  1. Root · 1 generation backK874208 Bard Octapolar Electrode CatheterC.R. Bard, Inc. · 1987
  2. This deviceK030187 Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K874208Bard Octapolar Electrode CatheterC.R. Bard, Inc.1987—
0 (this device)K030187Reprocessed Electrophysiology CatheterAlliance Medical, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199910
FIG. 1 — Lineage of K030187, 1987–2003Source: 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? (4)

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
*K891908Bard (R) Tip Deflecting Electrode Catheter
Summary page 5
…er or Electrode Recording Catheter Classification Name: Electrode Recording Catheter Predicate device(s): K891908 Bard Tip Deflecting Electrode Catheter K874208 Bard Octapolar Electrode Catheter K881966 Electr…
C.R. Bard, Inc.1989—
*K874208Bard Octapolar Electrode Catheter
Summary page 5
…Classification Name: Electrode Recording Catheter Predicate device(s): K891908 Bard Tip Deflecting Electrode Catheter K874208 Bard Octapolar Electrode Catheter K881966 Electrophysiology Electrode Catheter wit? Silver/Silver…
C.R. Bard, Inc.1987—
*K881966Electrophysiology Electrode Cath. W/Silver/Silver
Summary page 5
…ng Catheter Predicate device(s): K891908 Bard Tip Deflecting Electrode Catheter K874208 Bard Octapolar Electrode Catheter K881966 Electrophysiology Electrode Catheter wit? Silver/Silver K992373 Orbiter ST Diagnostic Electrode Catheter Devic…
C.R. Bard, Inc.1988—
*K992373Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable
Summary page 5
…lectrode Catheter K874208 Bard Octapolar Electrode Catheter K881966 Electrophysiology Electrode Catheter wit? Silver/Silver K992373 Orbiter ST Diagnostic Electrode Catheter Device description: Diagnostic electrophysiology (EP) catheters are specially…
C.R. Bard, Inc.1999—

Also cleared against K891908: 4 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)

Recalls of this device

DateClassRecallRoot causeReason
Aug 18, 2026Class IIZ-0085-2027Packaging process controlDiagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from…
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 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 28 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • 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 Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Reprocessed Electrophysiology 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.

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
  • K012708Electrophysiology CatheterAlliance Medical Corp. · 200229 recalls
  • K955847Gyro Tip EP CatheterCardiac Assist Devices, Inc. · 1997

More from Alliance Medical, Inc.

11 FDA decisions under this applicant name. See the company

  • K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 20061 recall
  • K050518Reprocessed Phacoemuisification TipsAlliance Medical, Inc. · 2005
  • K021654Reprocessed Compression SleeveAlliance Medical, Inc. · 2003
  • K012634Reprocessed External Fixation DeviceAlliance Medical, Inc. · 2002
  • K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001

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/K030187 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030187: Reprocessed 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/K030187

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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