510(k) · Cleared
ClearedAPRO 55 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 Apr 28, 2025 as substantially equivalent to K232971 (Alembic, LLC, 2024) after a 28-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Apr 28, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K003410 (2001). 15 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 11 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations between
- 3 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- 2 generations backK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018
- 1 generation backK232971 APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 2024
- This deviceK250958 APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
Show all 11 generations
- Root · 11 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 10 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 9 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 8 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 7 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 6 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 5 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 4 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 3 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- 2 generations backK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018
- 1 generation backK232971 APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 2024
- This deviceK250958 APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −10 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −9 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −8 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −7 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −6 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −5 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −4 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −3 | K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016 | — |
| −2 | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access… | Stryker | 2018 | — |
| −1 | K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2024 | — |
| 0 (this device) | K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 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 |
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 |
|---|---|---|---|
| * | K232971 | APRO 55 Catheter and Alembic Aspiration TubingSummary page 5…ication Name Percutaneous Catheter Regulation Number 21 CFR 870.1250 Product Code NRY Predicate Device K232971 APRO 55 Catheter and Alembic Aspiration Tubing Reference Device K243287 APRO 70 Swift Catheter and Alembic Aspir… | 2024 |
| † | K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | 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 1.8 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K232971.
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?
The APRO 55 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 55 Swift Catheter to the aspiration pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250958: APRO 55 Swift Catheter and Alembic Aspiration Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250958
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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