510(k) · Cleared
ClearedMillipede 088 Access Catheter; Millipede 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 Sep 20, 2024 as substantially equivalent to K233648 (Perfuze, Ltd., 2023) and 1 other predicate after a 29-day review. Its family tree reaches back 11 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 20, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K010954 (2001). 29 ancestors in all, the oldest K010853 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 7 generations between
- 3 generations backK214048 Millipede 088 Access CatheterPerfuze, Ltd. · 2022
- 2 generations backK231802 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- 1 generation backK233648 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- This deviceK242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter…Perfuze, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK250012 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253901 Millipede88 Access CatheterPerfuze, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252392 Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 10 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 9 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 8 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 7 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 6 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- 5 generations backK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018
- 4 generations backK203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM…Imperative Care, Inc. · 2021
- 3 generations backK214048 Millipede 088 Access CatheterPerfuze, Ltd. · 2022
- 2 generations backK231802 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- 1 generation backK233648 Millipede 088 Access CatheterPerfuze, Ltd. · 2023
- This deviceK242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter…Perfuze, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025 · cites it directly1descendant
- K253901Millipede88 Access CatheterPerfuze, Ltd. · 2026 · cites it directly0descendants
- K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −10 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −9 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −8 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −7 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −6 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| −5 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay… | Imperative Care, Inc. | 2018 | — |
| −4 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large… | Imperative Care, Inc. | 2021 | — |
| −3 | K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2022 | — |
| −2 | K231802 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023 | — |
| −1 | K233648 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023 | — |
| 0 (this device) | 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 | — |
| +1 | K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K233648 | Millipede 088 Access CatheterSummary page 5…ion: 21 CFR 870.1250 Product Code: QJP Manufacturer: Perfuze Ltd. 510(k) Number: K233648 Subject Device Proprietary Name: Millipede 070 Aspiration Catheter; Perfuze… | 2023 |
| * | K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetSummary page 5…ion: 21 CFR 870.1250 Product Code: NRY Manufacturer: Perfuze Ltd. 510(k) Number: K232524 Page 1 of 7 Device Description Millipe… | 2023 |
What descends from it? (3)
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)
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 23 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 29 ancestors have a recall of any class.
- Of its descendants, K250012 (Perfuze, Ltd., 2025) has gone furthest, with 1 descendant 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. 2024, 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 088 Access Catheter The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. 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…
Read the full statement (134 words)
Millipede 088 Access Catheter
The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
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/K242504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242504: Millipede 088 Access Catheter; 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/K242504
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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