510(k) · Cleared
ClearedNeVasc Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesalio, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Nov 10, 2025 as substantially equivalent to K211654 (Penumbra, Inc., 2021) after a 223-day review. Its family tree reaches back 12 generations to 2001. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 10, 2025
- Review
- 223 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003410 (2001). 17 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- 2 generations backK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- 1 generation backK211654 Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2021
- This deviceK251006 NeVasc Aspiration SystemVesalio, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 11 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 10 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 9 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 8 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 7 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 6 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 5 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 4 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- 3 generations backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- 2 generations backK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- 1 generation backK211654 Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2021
- This deviceK251006 NeVasc Aspiration SystemVesalio, Inc. · 2025
Class I recalls in this family
- K162901 Penumbra 3D Revascularization Device3 generations back · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −11 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −10 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −9 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −8 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −7 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −6 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −5 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −4 | K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016 | — |
| −3 | K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| −2 | K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2018 | — |
| −1 | K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2021 | — |
| 0 (this device) | K251006 | NeVasc Aspiration System | Vesalio, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 NRY device
- #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211654 | Penumbra System (Reperfusion Catheter RED 72)Summary page 5…FR 870.1250 Predicate: Proprietary Name: Penumbra System (Reperfusion Catheter RED 72) Product Code: NRY 510(k) Number: K211654 1 Device Description: The Ne… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 3 generations back · ◆ in the 2017 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K211654.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NRY
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRY
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NRY
4in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · NRY
565in 2025
MAUDE reports naming product code NRY, 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 | 5 | 94 | 0 | 13 |
| 2008 | 2 | — | 0 | 18 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 289 |
| 2011 | 2 | — | 0 | 263 |
| 2012 | 4 | 90 | 0 | 366 |
| 2013 | 0 | — | 1 | 405 |
| 2014 | 4 | 140 | 0 | 428 |
| 2015 | 6 | 128 | 0 | 598 |
| 2016 | 5 | 75 | 0 | 497 |
| 2017 | 3 | 185 | 4 | 432 |
| 2018 | 11 | 156 | 0 | 415 |
| 2019 | 7 | 89 | 0 | 650 |
| 2020 | 6 | 125 | 4 (4) | 703 |
| 2021 | 9 | 80 | 0 | 688 |
| 2022 | 3 | 129 | 0 | 549 |
| 2023 | 8 | 112 | 0 | 711 |
| 2024 | 8 | 165 | 0 | 641 |
| 2025 | 15 | 129 | 0 | 565 |
| 2026 | 14 | 147 | 2 | — |
What is it indicated for?
NeVasc Aspiration Catheter: As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio Aspiration Tubing Set and a compatible aspiration pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients…
Read the full statement (113 words)
NeVasc Aspiration Catheter:
As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio Aspiration Tubing Set and a compatible aspiration pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Vesalio Aspiration Tubing Set:
As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251006 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251006: NeVasc Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251006
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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