510(k) · Cleared
ClearedReprocessed Inquiry Steerable Diagnostic EP Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Mar 5, 2021 as substantially equivalent to K171277 (Innovative Health, LLC, 2017) and 2 other predicates after a 120-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Mar 5, 2021
- Review
- 120 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961924 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK961924 Ibi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. · 1997 · Recalled
- 1 generation backK171277 Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2017
- This deviceK203261 Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2021
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 | K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2017 | — |
| 0 (this device) | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (3)
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 |
|---|---|---|---|
| * | K171277 | Reprocessed Inquiry Steerable Diagnostic EP CatheterSummary page 5…Product Code: NLH Predicate Device: 510(k) Number 510(k) Title Manufacturer K171277 Reprocessed Inquiry Steerable Innovative Health, LLC. Diagnostic E… | 2017 |
| * | K982232 | Modification of the Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 5…er K171277 Reprocessed Inquiry Steerable Innovative Health, LLC. Diagnostic EP Catheter K982232 Modification of the IBI-1100 Steerable Irvine Biomedical, Inc. Electrophysi… | 1998 |
| * | K961924 | Ibi-1100 Steerable Electrophysiology Catheter SystemSummary page 5…K982232 Modification of the IBI-1100 Steerable Irvine Biomedical, Inc. Electrophysiology Catheter System K961924 IBI-1100 Steerable Electrophysiology Irvine Biomedical, Inc. Catheter Sys… | 1997 |
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 24 years and passes through 2 companies; a new generation was cleared every 20.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2021, 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 Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203261: Reprocessed Inquiry Steerable Diagnostic EP Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203261
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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