510(k) · Cleared
ClearedMillipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perfuze, Ltd. · NRY Catheter, Thrombus Retriever
Cleared on Oct 18, 2023 as substantially equivalent to K173200 (MicroVention, Inc., 2018) after a 61-day review. Its family tree reaches back 9 generations to 2001. 4 later devices descend from it.
- Decided
- Oct 18, 2023
- Review
- 61 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003410 (2001). 12 ancestors in all, the oldest K003086 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 1 generation backK173200 SOFIA Plus Aspiration CatheterMicroVention, Inc. · 2018
- This deviceK232524 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter…Perfuze, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK250012 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253901 Millipede88 Access CatheterPerfuze, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252392 Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 7 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 6 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 5 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 4 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 1 generation backK173200 SOFIA Plus Aspiration CatheterMicroVention, Inc. · 2018
- This deviceK232524 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd. · 2024 · cites it directly3descendants
- K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025 · 2 generations on1descendant
- K253901Millipede88 Access CatheterPerfuze, Ltd. · 2026 · 2 generations on0descendants
- K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −8 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −7 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −6 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −5 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −4 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −3 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −2 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −1 | K173200 | SOFIA Plus Aspiration Catheter | MicroVention, Inc. | 2018 | — |
| 0 (this device) | K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2023 | — |
| +1 | K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze… | Perfuze, Ltd. | 2024 | — |
| +2 | K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025 | — |
| +2 | K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026 | — |
| +3 | K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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.
Planning a device in NRY? 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 |
|---|---|---|---|
| * | K173200 | SOFIA Plus Aspiration CatheterSummary page 4…t Code: NRY Manufacturer: MicroVention, Inc. 510(k) Number: K173200 Device Description The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rot… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration… | 2024 | 3 |
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K242504 (Perfuze, Ltd., 2024) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Millipede 070 Aspiration Catheter The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube 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…
Read the full statement (105 words)
Millipede 070 Aspiration Catheter
The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Perfuze Aspiration Tube Set
The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232524: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232524
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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