510(k) · Cleared
Recalled · Class II · 2023Fogarty (R) Thru-Lumen Embolectomy 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 20, 1989 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 1989
- Review
- 104 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 1
- Predicates
- 0
53 later devices descend from it, 6 citing it directly.
- This deviceK892410 Fogarty (R) Thru-Lumen Embolectomy CatheterBaxter Healthcare Corp · 1989
- Descendant · cites it directly · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
- Descendant · cites it directly · 6 of its ownK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · cites it directly35descendants
- K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · 2 generations on6descendants
- K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical · 2016 · 2 generations on6descendants
- K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011 · cites it directly6descendants
- K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892410 | Fogarty (R) Thru-Lumen Embolectomy Catheter | Baxter Healthcare Corp | 1989 | — |
| +1 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| +2 | K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017 | — |
| +2 | K162970 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction… | Inari Medical | 2016 | — |
| +1 | K110315 | Nexgen Peripheral Mechanical Retrieval Device | Nexgen Medical Systems, Inc. | 2011 | — |
| +1 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (53)
See all 536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143563 | Infusion Aspiration Catheter System | 2015 | 35 |
| K110315 | Nexgen Peripheral Mechanical Retrieval Device | 2011 | 6 |
| K080901 | Lbi Embolectomy System | 2008 | 6 |
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | 2024 | 0 |
| K100840 | Embo Plus Embolectomy Catheter | 2010 | 0 |
| K982141 | Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025 | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2023 | Class II | Z-0238-2024 | Nonconforming Material/Component | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143563 (Inari Medical, Inc., 2015) has gone furthest, with 35 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/K892410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K892410
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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