510(k) · Cleared
ClearedRadia Steerable Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jun 5, 2009 as substantially equivalent to K992373 (C.R. Bard, Inc., 1999) after a 28-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 5, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992373 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992373 Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension CableC.R. Bard, Inc. · 1999
- This deviceK091370 Radia Steerable Diagnostic CatheterC.R. Bard, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992373 | Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable | C.R. Bard, Inc. | 1999 | — |
| 0 (this device) | K091370 | Radia Steerable Diagnostic Catheter | C.R. Bard, Inc. | 2009 | — |
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 13.7 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992373 | Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension CableSummary page 1…Diagnostic electrode catheter Class: Class 11,21 CER 870.1220, Product Code DRE Predicate Device(s): * Orbiter ST Diagnostic Electrode Catheter (K992373) * EP*XT Steerable Electrode Catheter (previously known as Bard Steerable Catheter) (K921 872A) Device Description: The Ra… | 1999 |
| Kept off the family tree | K921872 | EP*XT Steerable Electrode Catheter (previously known as Bard Steerable Catheter) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…RE Predicate Device(s): * Orbiter ST Diagnostic Electrode Catheter (K992373) * EP*XT Steerable Electrode Catheter (previously known as Bard Steerable Catheter) (K921 872A) Device Description: The Radia T M Steerable Diagnostic Catheter is a steerable atrial mapping EP catheter with up to 20 electr… |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K992373.
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. 2009, 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?
Bard Electrophysiology's steerable diagnostic electrode catheters are intended for
temporary intracardiac sensing, recording, stimulation and temporary pacing during the
evaluation of cardiac arrhythmias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091370 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091370: Radia Steerable Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091370
Report an extraction error
Are you the manufacturer?
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