510(k) Report

510(k) · Cleared

Cleared

Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter

K042775510(k) SpecialCleared Nov 4, 200429-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

Irvine Biomedical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Nov 4, 2004 as substantially equivalent to K010471 (Irvine Biomedical, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1997. 40 later devices descend from it.

Decided
Nov 4, 2004
Review
29 days
Class
Class II
Product code
DRF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K961924 (1997). 2 ancestors in all. 40 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2010: 2 descendants cleared2006: 3 descendants cleared2016: 3 descendants cleared2008: 2 descendants cleared2011: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2018: 2 descendants cleared2020: 3 descendants cleared2019: 2 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2025: 6 descendants cleared2026: 5 descendants cleared2022: 2 descendants cleared2023: 1 descendant clearedK961924 · Ibi-1100 Steerable Electrophysiology Catheter System · Irvine Biomedical, Inc. · 1997 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 4 descendants10 generations forward: 2 descendants11 generations forward: 2 descendants K961924 · Ibi-1100 Steerable Electrophysiology Catheter System · Irvine Biomedical, Inc. · 1997 · recalled0+5+10
  1. Root · 1 generation backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
  2. This deviceK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
  3. Descendant · cites it directly · 25 of its ownK160335 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni…St Jude Medical · 2016
  4. Descendant · 2 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
  5. Descendant · 2 generations on · 18 of its ownK192037 Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019
  6. Descendant · 2 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
  7. Descendant · 3 generations on · 13 of its ownK212061 EnSite X EP SystemAbbott · 2021

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2006: 32007: 12008: 22009: 22010: 22011: 12016: 32018: 22019: 22020: 32021: 32022: 22023: 12024: 22025: 62026: 5
2006high 6 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 40 · See all
  • K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…St Jude Medical · 2016 · cites it directly25descendants
  • K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 2 generations on21descendants
  • K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical · 2019 · 2 generations on18descendants
  • K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 2 generations on17descendants
  • K212061EnSite X EP SystemAbbott · 2021 · 3 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961924Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc.19972
0 (this device)K042775Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc.2004—
+1K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor…St Jude Medical2016—
+2K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.2018—
+2K192037Advisor VL Circular Mapping Catheter, Sensor EnabledAbbott Medical2019—
+2K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled…Abbott Medical2020—
+3K212061EnSite X EP SystemAbbott2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200710
200820
200920
201020
201110
201630
201820
201920
202030
202130
202220
202310
202420
202560
202650
FIG. 1 — Lineage of K042775, 1997–2026Source: 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 DRF? 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 DRF device

  1. #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 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? (2)

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
*K010471Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569
Summary page 1
…Company: Irvine Biomedical, Inc. Device: InquiryTM AFocusT M Steerable Electrophysiology Catheter 510(k): K010471 Date Cleared: June 6, 2001 Company: Irvine Biomedical, Inc. Device:…
Irvine Biomedical, Inc.2001—
*K961924Ibi-1100 Steerable Electrophysiology Catheter System
Summary page 1
…pany: Irvine Biomedical, Inc. Device: IBI- 1100 InquiryTM Steerable Electrophysiology Catheter System 510(k): K961924 Date Cleared: April 11, 1997 035…
Irvine Biomedical, Inc.19972

Also cleared against K010471: 3 other devices →

What descends from it? (40)

See all 40

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

NumberDeviceApplicantDecidedDescendants
K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…St Jude Medical201625
K062251Reflexion Spiral Variable Radius Catheter, Model 402804St Jude Medical20065
K060757Inquiry Optima Plus Steerable Electrophysiology CatheterIrvine Biomedical, Inc.20063
K082061Inquiry H-Curve TV Steerable Diagnostic CatheterIrvine Biomedical, Inc.20081
K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20081
K053582Inquiry Afocus II Diagnostic CatheterIrvine Biomedical, Inc.20061
K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry…Innovative Health, LLC20160
K160496Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC20160
K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions20110
K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20100

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K160335 (St Jude Medical, 2016) has gone furthest, with 25 descendants of its own.
  • 3 other devices also cite its predicate K010471.

How does its category compare?

All DRF devices

DRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRF

3in 2025

2007: 22008: 22009: 72010: 52011: 32012: 12013: 22014: 12015: 32016: 82017: 72018: 12019: 102020: 42021: 122022: 82023: 52024: 42025: 32026 (partial year): 2
2007high 12 (2021) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRF

45in 2023

2009: 243 days median2010: 65 days median2011: 190 days median2015: 29 days median2016: 175 days median2019: 163 days median2021: 124 days median2022: 283 days median2023: 45 days median
2007high 283 (2022) · low 29 (2015)2026

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

Recalls per year · DRF

1in 2015

2007: 22008: 42011: 62014: 22015: 1
2007high 6 (2011) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRF

508in 2025

2007: 1202008: 1762009: 1222010: 1302011: 2452012: 4022013: 3102014: 3492015: 3272016: 3832017: 4582018: 7232019: 6692020: 6512021: 6252022: 6132023: 6852024: 6232025: 508
2007high 723 (2018) · low 120 (2007)2025

MAUDE reports naming product code DRF, 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
20072—2120
20082—4176
200972430122
20105650130
201131906245
20121—0402
20132—0310
20141—2349
20153291327
201681750383
20177—0458
20181—0723
2019101630669
20204—0651
2021121240625
202282830613
20235450685
20244—0623
20253—0508
20262—0—

What is it indicated for?

The Steerable Electrophysiology Catheter is used for electrogram recording and cardiac

stimulation during diagnostic electrophysiologic studies. The catheter is indicated for mapping

the atrial regions of the heart.

Indications for use as stated in the FDA summary.

Also cleared against K010471

3 other devices cite the same predicate.

  • K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011
  • K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc. · 2010
  • K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008

More from Irvine Biomedical, Inc.

118 FDA decisions under this applicant name. See the company

  • P040014/S052Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation CatheterIrvine Biomedical, Inc. · 2026
  • P040014/S051Ampere GeneratorIrvine Biomedical, Inc. · 2026
  • P060019/S059Ampere GeneratorIrvine Biomedical, Inc. · 2026
  • P060019/S058Cool Point™ Tubing SetIrvine Biomedical, Inc. · 2025
  • P060019/S057Ibi Therapy Cool Path Ablation Catheter & Ibi-1500T9 RFIrvine Biomedical, Inc. · 2025

Recent decisions in DRF

The DRF category page

  • K262068Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)CathRx, Ltd. · 2026
  • K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. · 2026
  • K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc. · 2025
  • K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation · 2025
  • P990025/S074NAVISTAR Electrophysiology CatheterBiosense Webster, Inc. · 2025

https://510kreport.com/device/K042775 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042775

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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