510(k) · Cleared
ClearedSteerocath II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ep Technologies, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Dec 16, 1993 after a 489-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 16, 1993
- Review
- 489 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK924109 Steerocath IIEp Technologies, Inc. · 1993
- Descendant · cites it directly · 5 of its ownK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
- Descendant · cites it directly · 0 of its ownK052414 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK052603 Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK043392 Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K012708Electrophysiology CatheterAlliance Medical Corp. · 2002 · cites it directly5descendants
- K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005 · cites it directly1descendant
- K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005 · cites it directly0descendants
- K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp. · 2005 · 2 generations on0descendants
- K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924109 | Steerocath II | Ep Technologies, Inc. | 1993 | — |
| +1 | K012708 | Electrophysiology Catheter | Alliance Medical Corp. | 2002 | 29 |
| +1 | K043393 | Reprocessed EP Technologies Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
| +1 | K052414 | Reprocessed Electrophysiology Catheter | Alliance Medical Corp. | 2005 | — |
| +2 | K052603 | Reprocessed Daig Livewire Electrophysiology Catheters | Alliance Medical Corp. | 2005 | 26 |
| +2 | K043392 | Reprocessed Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K012708 (Alliance Medical Corp., 2002) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K924109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924109: Steerocath II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924109
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026