510(k) · Cleared
ClearedInquiry Afocusii Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Aug 13, 2010 as substantially equivalent to K042775 (Irvine Biomedical, Inc., 2004) and 1 other predicate after a 65-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Aug 13, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K961924 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 4 generations backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
- 3 generations backK062251 Reflexion Spiral Variable Radius Catheter, Model 402804St Jude Medical · 2006
- 2 generations backK072012 Reflexion Spiral Variable Radius CatheterSt Jude Medical · 2007
- 1 generation backK080179 Reflexion HD High-Density Mapping CatheterSt Jude Medical · 2009 · Recalled
- This deviceK101623 Inquiry Afocusii Diagnostic CatheterSt Jude Medical · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961924 | Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1997 | 2 |
| −4 | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable… | Irvine Biomedical, Inc. | 2004 | — |
| −3 | K062251 | Reflexion Spiral Variable Radius Catheter, Model 402804 | St Jude Medical | 2006 | — |
| −2 | K072012 | Reflexion Spiral Variable Radius Catheter | St Jude Medical | 2007 | — |
| −1 | K080179 | Reflexion HD High-Density Mapping Catheter | St Jude Medical | 2009 | 1 |
| 0 (this device) | K101623 | Inquiry Afocusii Diagnostic Catheter | St Jude Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
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 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterSummary page 1…Biomedical, Inc a St. Jude Medical Company Device: InquiryTm AFoCUSIITM Steerable Electrophysiology Catheter 5 10(k): K042775 Date Cleared: November 4, 2004 Company: St. Jude Medical Device: Reflexion HD1Tm High-Den… | 2004 |
| * | K080179 | Reflexion HD High-Density Mapping CatheterSummary page 1…Date Cleared: November 4, 2004 Company: St. Jude Medical Device: Reflexion HD1Tm High-Density Mapping Catheter 5 10(k): K080179 Date Cleared: January 7, 2009 14-1 4. A description of th… | 2009 |
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 1.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 10 other devices also cite its predicate K042775.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The InquiryTm AFocusIITm Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The InquiryTm AFocusIITm Diagnostic Catheters are to be used to map the atrial regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101623: Inquiry Afocusii Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101623
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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