510(k) · Cleared
ClearedAPRO 35 Swift Catheter and Alembic Aspiration Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alembic, LLC · NRY Catheter, Thrombus Retriever
Cleared on Aug 12, 2026 as substantially equivalent to K251015 (Alembic, LLC, 2025) after a 29-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Aug 12, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003410 (2001). 16 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018
- 2 generations backK232971 APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 2024
- 1 generation backK251015 APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
- This deviceK262391 APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2026
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 backK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018
- 2 generations backK232971 APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 2024
- 1 generation backK251015 APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
- This deviceK262391 APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2026
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 | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access… | Stryker | 2018 | — |
| −2 | K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2024 | — |
| −1 | K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025 | — |
| 0 (this device) | K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K251015 | APRO 45 Catheter and Alembic Aspiration TubingSummary page 5…NRY Review Panel: Neurology 3) Legally Marketed Predicate Device Predicate Device: K251015 APRO® 45 Catheter and Alembic Aspiration Tubing 4) Device Description The APRO® 35 Swift Catheter is a… | 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 25 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 16 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. 2026, 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?
The APRO® 35 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended 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.
The Alembic Aspiration Tubing is intended to connect the APRO® 35 Swift Catheter to the aspiration pump.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K262391: APRO 35 Swift Catheter and Alembic Aspiration Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K262391
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026