510(k) · Cleared
ClearedOrthogonal EP Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Biomedical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jun 3, 1999 after a 73-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jun 3, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK990958 Orthogonal EP CathetersIrvine Biomedical, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK081329 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008
- Descendant · cites it directly · 0 of its ownK112232 Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011
- Descendant · cites it directly · 0 of its ownK101789 Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008 · cites it directly1descendant
- K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011 · cites it directly0descendants
- K101789Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990958 | Orthogonal EP Catheters | Irvine Biomedical, Inc. | 1999 | — |
| +1 | K081329 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | 2008 | — |
| +1 | K112232 | Reprocessed Electrophysiology Catheters | Stryker Sustainability Solutions | 2011 | — |
| +1 | K101789 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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?
The FDA summary names no predicate by 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, K081329 (Ascent Healthcare Solutions, 2008) has gone furthest, with 1 descendant 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?
The ORTHOGONAL™ Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The electrophysiology 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/K990958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990958: Orthogonal EP Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990958
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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