510(k) · Cleared
Recalled · Class II · 2017Fogarty Arterial Embolectomy II Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · DXE Catheter, Embolectomy
Cleared on Jul 6, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 6, 1990
- Review
- 88 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK901625 Fogarty Arterial Embolectomy II CatheterBaxter Healthcare Corp · 1990
- Descendant · cites it directly · 2 of its ownK100842 Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon…Hotspur Technologies · 2010
- Descendant · 2 generations on · 1 of its ownK223613 InThrill Thrombectomy SystemInari Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK250421 InThrill™ Thrombectomy SystemInari Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233619 Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences · 2024
Most influential descendants
Showing 4 of 4 · See all- K100842Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CMHotspur Technologies · 2010 · cites it directly2descendants
- K223613InThrill Thrombectomy SystemInari Medical, Inc. · 2023 · 2 generations on1descendant
- K250421InThrill™ Thrombectomy SystemInari Medical, Inc. · 2025 · 3 generations on0descendants
- K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards Lifesciences · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901625 | Fogarty Arterial Embolectomy II Catheter | Baxter Healthcare Corp | 1990 | — |
| +1 | K100842 | Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CM | Hotspur Technologies | 2010 | — |
| +2 | K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | 2023 | — |
| +3 | K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | 2025 | — |
| +1 | K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 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? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2017 | Class II | Z-3077-2017 | Packaging | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100842 (Hotspur Technologies, 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K901625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901625: Fogarty Arterial Embolectomy II Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901625
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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