510(k) · Cleared
ClearedReflexion Spiral Variable Radius Catheter, Model 402804
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 Oct 20, 2006 as substantially equivalent to K042775 (Irvine Biomedical, Inc., 2004) after a 78-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961924 (1997). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 1 generation backK042775 Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable…Irvine Biomedical, Inc. · 2004
- This deviceK062251 Reflexion Spiral Variable Radius Catheter, Model 402804St Jude Medical · 2006
- Descendant · cites it directly · 4 of its ownK072012 Reflexion Spiral Variable Radius CatheterSt Jude Medical · 2007
- Descendant · 2 generations on · 1 of its ownK080179 Reflexion HD High-Density Mapping CatheterSt Jude Medical · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK191170 Reprocessed Reflexion Spiral Bi-Directional Variable Radius…Innovative Health, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK101623 Inquiry Afocusii Diagnostic CatheterSt Jude Medical · 2010
- Descendant · cites it directly · 0 of its ownK090323 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2009
Most influential descendants
Showing 5 of 5 · See all- K072012Reflexion Spiral Variable Radius CatheterSt Jude Medical · 2007 · cites it directly4descendants
- K080179Reflexion HD High-Density Mapping CatheterSt Jude Medical · 2009 · 2 generations on1descendant
- K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterInnovative Health, LLC · 2019 · 2 generations on0descendants
- K101623Inquiry Afocusii Diagnostic CatheterSt Jude Medical · 2010 · 3 generations on0descendants
- K090323Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961924 | Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1997 | 2 |
| −1 | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable… | Irvine Biomedical, Inc. | 2004 | — |
| 0 (this device) | K062251 | Reflexion Spiral Variable Radius Catheter, Model 402804 | St Jude Medical | 2006 | — |
| +1 | K072012 | Reflexion Spiral Variable Radius Catheter | St Jude Medical | 2007 | — |
| +2 | K080179 | Reflexion HD High-Density Mapping Catheter | St Jude Medical | 2009 | 1 |
| +2 | K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology… | Innovative Health, LLC | 2019 | — |
| +3 | K101623 | Inquiry Afocusii Diagnostic Catheter | St Jude Medical | 2010 | — |
| +1 | K090323 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2019 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterSummary page 1…lass II, 21 CFR 870.1220, Product Code DRF 3. Predicate Device: Irvine Biomedical, Inc., (IBI) InquiryTM OptimaTM Steerable Electrophysiology Catheter (K042775) 4. Device Description: The St. Jude Medical (SJM) Reflexion SpirafTM Variable Radius Catheter (Reflexion Spiral catheter) is a… | 2004 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K072012 (St Jude Medical, 2007) has gone furthest, with 4 descendants of its own.
- 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.
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 Reflexion SpiralTM catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion SpiralTM catheter is to be used to map the atrial regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062251: Reflexion Spiral Variable Radius Catheter, Model 402804.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062251
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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