510(k) Report

510(k) · Cleared

Cleared

Reprocessed Electrophysiology Diagnostic Catheters

K101789510(k) TraditionalCleared Aug 19, 201052-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

Sterilmed, Inc. · NLH Catheter, Recording, Electrode, Reprocessed

Cleared on Aug 19, 2010 as substantially equivalent to K060757 (Irvine Biomedical, Inc., 2006) and 7 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1997.

Decided
Aug 19, 2010
Review
52 days
Class
Class II
Product code
NLH
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K961924 (1997). 8 ancestors in all, the oldest K946333 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestorK961924 · Ibi-1100 Steerable Electrophysiology Catheter System · Irvine Biomedical, Inc. · 1997 · recalledK042775 · Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter · Irvine Biomedical, Inc. · 2004K053582 · Inquiry Afocus II Diagnostic Catheter · Irvine Biomedical, Inc. · 20061995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors K053582 · Inquiry Afocus II Diagnostic Catheter · Irvine Biomedical, Inc. · 2006K042775 · Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter · Irvine Biomedical, Inc. · 2004K961924 · Ibi-1100 Steerable Electrophysiology Catheter System · Irvine Biomedical, Inc. · 1997 · recalled0
  1. Root · 3 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
  2. 2 generations backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
  3. 1 generation backK053582 Inquiry Afocus II Diagnostic CatheterIrvine Biomedical, Inc. · 2006
  4. This deviceK101789 Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961924Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc.19972
−2K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc.2004—
−1K053582Inquiry Afocus II Diagnostic CatheterIrvine Biomedical, Inc.2006—
0 (this device)K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810
199910
200110
200610
FIG. 1 — Lineage of K101789, 1997–2010Source: 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? (8)

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
*K060757Inquiry Optima Plus Steerable Electrophysiology Catheter
Summary page 1
…Predicate Devices: The reprocessed lEP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomed…
Irvine Biomedical, Inc.2006—
*K053582Inquiry Afocus II Diagnostic Catheter
Summary page 1
…te Devices: The reprocessed lEP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomedical liP…
Irvine Biomedical, Inc.2006—
*K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter
Summary page 1
…s: The reprocessed lEP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomedical liP diagnosti…
Irvine Biomedical, Inc.2004—
*K010471Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569
Summary page 1
…e reprocessed lEP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomedical liP diagnostic catheter…
Irvine Biomedical, Inc.2001—
*K990958Orthogonal EP Catheters
Summary page 1
…essed lEP diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomedical liP diagnostic catheters consist…
Irvine Biomedical, Inc.1999—
*K982232Modification of the Ibi-1100 Steerable Electrophysiology Catheter System
Summary page 1
…diagnostic catheters are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomedical liP diagnostic catheters consist of a sha…
Irvine Biomedical, Inc.1998—
*K961924Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc.19972
*K946333Ibi-1000(TM) Electrophysiology Cathter
Summary page 1
…are substantially equivalent to Irvine Biomedical, Inc. catheters (5 10(k)'s K060757, K053582, K042775, K(010471, K990958, K982232, K96I924, and K946333). Device Description: SterilMed Reprocessed Irvine Biomedical liP diagnostic catheters consist of a shaft with a handle at th…
Irvine Biomedical, Inc.1995—

Also cleared against K060757: 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 13 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K060757.

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 electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

Indications for use as stated in the FDA summary.

Also cleared against K060757

2 other devices cite the same predicate.

  • K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable…Innovative Health, LLC · 2016
  • K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011

More from Sterilmed, Inc.

65 FDA decisions under this applicant name. See the company

  • K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825)…Sterilmed, Inc. · 2026
  • K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc. · 2024
  • K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc. · 2019
  • K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc. · 2019
  • K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc. · 2019

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/K101789 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101789: Reprocessed Electrophysiology Diagnostic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101789

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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