510(k) · Cleared
ClearedMillipede70 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 Aug 29, 2025 as substantially equivalent to K250012 (Perfuze, Ltd., 2025) after a 29-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Aug 29, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K010954 (2001). 31 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 13 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 9 generations between
- 3 generations backK233648 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- 2 generations backK242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter…Perfuze, Ltd. · 2024
- 1 generation backK250012 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
- This deviceK252392 Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 12 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 11 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 10 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 9 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 8 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- 7 generations backK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- 6 generations backK203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM…Imperative Care, Inc. · 2021
- 5 generations backK214048 Millipede 088 Access CatheterPerfuze, Ltd. · 2022
- 4 generations backK231802 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- 3 generations backK233648 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- 2 generations backK242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter…Perfuze, Ltd. · 2024
- 1 generation backK250012 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
- This deviceK252392 Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −12 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −11 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −10 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −9 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −8 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| −7 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| −6 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… | Imperative Care, Inc. | 2021 | — |
| −5 | K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2022 | — |
| −4 | K231802 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023 | — |
| −3 | K233648 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023 | — |
| −2 | K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze… | Perfuze, Ltd. | 2024 | — |
| −1 | K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetSummary page 5…Product Code: NRY Manufacturer: Perfuze Ltd. 510(k) Number: K250012 Device Description The Millipede70 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotat… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 31 ancestors have a recall of any class.
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?
Millipede70 Aspiration Catheter The Millipede70 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 (103 words)
Millipede70 Aspiration Catheter
The Millipede70 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 thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
Perfuze Aspiration Tube Set
The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252392 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252392: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252392
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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