510(k) · Cleared
ClearedOrbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable
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 Nov 5, 1999 after a 113-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 5, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK992373 Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension CableC.R. Bard, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK161393 Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC · 2016
- Descendant · cites it directly · 0 of its ownK091370 Radia Steerable Diagnostic CatheterC.R. Bard, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK030187 Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 2003 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC · 2016 · cites it directly0descendants
- K091370Radia Steerable Diagnostic CatheterC.R. Bard, Inc. · 2009 · cites it directly0descendants
- K030187Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992373 | Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable | C.R. Bard, Inc. | 1999 | — |
| +1 | K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016 | — |
| +1 | K091370 | Radia Steerable Diagnostic Catheter | C.R. Bard, Inc. | 2009 | — |
| +1 | K030187 | Reprocessed Electrophysiology Catheter | Alliance Medical, Inc. | 2003 | 28 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 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 13.7 · 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? (4)
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 |
|---|---|---|---|
| * | — | Viking Diagnostic Electrode Catheter Named without a submission number | |
| * | — | Bard EPeXT Electrode Catheter Named without a submission number | |
| * | — | Bard Woven Electrode Catheter Named without a submission number | |
| * | — | Cordis Webster Electrophysiology Catheter Named without a submission number |
What descends from it? (3)
3 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?
- Of its descendants, K161393 (Innovative Health, LLC, 2016) has gone furthest, with 0 descendants of its own.
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?
Bard Electrophysiology’s steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
The Orbiter ST extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.
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/K992373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992373: Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992373
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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