510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Reprocessed CS BI-Diectional Diagnostic Electrophysiology Catheter

K100254510(k) TraditionalCleared May 28, 2010120-day reviewClass II21 CFR 870.1220Recalls 27

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

Ascent Healthcare Solutions · NLH Catheter, Recording, Electrode, Reprocessed

Cleared on May 28, 2010 as substantially equivalent to K050877 (Biosense Webster, Inc., 2005) after a 120-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it. It has been recalled 27 times.

Decided
May 28, 2010
Review
120 days
Class
Class II
Product code
NLH
Recalls
27
Predicates
1

Its longest line of descent runs back 1 generation to K050877 (2005). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant clearedK050877 · Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR · Biosense Webster, Inc. · 200520052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K050877 · Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR · Biosense Webster, Inc. · 20050
  1. Root · 1 generation backK050877 Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc. · 2005
  2. This deviceK100254 Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions · 2010
  3. Descendant · cites it directly · 0 of its ownK181056 Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K181056Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K050877Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FRBiosense Webster, Inc.2005—
0 (this device)K100254Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions2010—
+1K181056Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K100254, 2005–2019Source: 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? (1)

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
*K050877Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR
Summary page 1
…ode recording catheter or electrode recording probe Predicate Device 51 0(k) Title Manufacturer K050877 Coronary Sinus Deflectable Mapping Biosense Webster, Inc. Catheter…
Biosense Webster, Inc.2005—

Also cleared against K050877: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181056Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions20190

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
Mar 29, 2018Class IIZ-2426-2018Use errorThrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

The 5 latest of 27 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K181056 (Stryker Sustainability Solutions, 2019) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K050877.

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. 2010, this device’s year, is highlighted.

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?

The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Indications for use as stated in the FDA summary.

Also cleared against K050877

1 other device cites the same predicate.

  • K090898Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with EZ SteerBiosense Webster, Inc. · 20091 recall

More from Ascent Healthcare Solutions

21 FDA decisions under this applicant name. See the company

  • K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions · 2011
  • K110189Reprocessed Electrosurgical InstrumentAscent Healthcare Solutions · 2011
  • K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 20101 recall
  • K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, GablueAscent Healthcare Solutions · 2010
  • K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 20101 recall

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/K100254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100254: Reprocessed CS BI-Diectional Diagnostic 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/K100254

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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