510(k) · Cleared
ClearedDiagnostic II Catheter
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 Jul 27, 1994 after a 201-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jul 27, 1994
- Review
- 201 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK940168 Diagnostic II CatheterEp Technologies, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002 · Recalled
- Descendant · cites it directly · 3 of its ownK081576 Blazer DX-20 Diagnostic CatheterBoston Scientific Corp · 2009
- Descendant · 2 generations on · 1 of its ownK211375 Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
- Descendant · 3 generations on · 0 of its ownK232651 BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K012708Electrophysiology CatheterAlliance Medical Corp. · 2002 · cites it directly5descendants
- K081576Blazer DX-20 Diagnostic CatheterBoston Scientific Corp · 2009 · cites it directly3descendants
- K211375Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2021 · 2 generations on1descendant
- K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005 · 2 generations on1descendant
- K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940168 | Diagnostic II Catheter | Ep Technologies, Inc. | 1994 | — |
| +1 | K012708 | Electrophysiology Catheter | Alliance Medical Corp. | 2002 | 29 |
| +1 | K081576 | Blazer DX-20 Diagnostic Catheter | Boston Scientific Corp | 2009 | — |
| +2 | K211375 | Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021 | — |
| +2 | K043393 | Reprocessed EP Technologies Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
| +3 | K232651 | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 5 | 0 |
| 2009 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 13.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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/K940168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940168: Diagnostic II Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940168
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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