510(k) · Cleared
ClearedOrbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110
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 Oct 23, 2003 as substantially equivalent to K971265 (C.R. Bard, Inc., 1997) after a 238-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 23, 2003
- Review
- 238 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971265 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971265 Viking Diagnostic Electrode CatheterC.R. Bard, Inc. · 1997
- This deviceK030627 Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110C.R. Bard, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971265 | Viking Diagnostic Electrode Catheter | C.R. Bard, Inc. | 1997 | — |
| 0 (this device) | K030627 | Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110 | C.R. Bard, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K971265 | Viking Diagnostic Electrode CatheterSummary page 2…eted Bard Orbiter ST Diagnostic Electrode catheter. Where appropriate, other Bard devices are referenced as supplemental predicate devices including the Viking catheter (K971265/FDA concurrence October 23, 1997) and the Woven catheter (Preamendment device). Refer to Appendix 4 for the instructions for Use… | 1997 |
| * | — | Orbiter ST Diagnostic Electrode Catheter Named without a submission number | |
| * | — | Bard Woven Electrode Catheter Named without a submission number |
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.
- 4 other devices also cite its predicate K971265.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030627: Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030627
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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