510(k) · Cleared
ClearedZenith Aspiration Catheter; Disposable Aspiration Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Zenith Vascular SciTech Limited · NRY Catheter, Thrombus Retriever
Cleared on May 20, 2026 as substantially equivalent to K113163 (Penumbra, Inc., 2011) and 2 other predicates after a 266-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- May 20, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K003410 (2001). 14 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 2 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- 1 generation backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- This deviceK252707 Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited · 2026
Show all 10 generations
- Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 7 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 6 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 5 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 4 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 2 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- 1 generation backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- This deviceK252707 Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −9 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −8 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −7 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −6 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −5 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −4 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −3 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −2 | K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016 | — |
| −1 | K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited | 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? (3)
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 |
|---|---|---|---|
| * | K113163 | Penumbra System MaxSummary page 5…Percutaneous Catheter Product Code NRY Device Classification Class II Penumbra System Max (K113163) Predicate Devices Penumbra Reperfusion Catheter 054 (K090752) Penumbra Syste… | 2011 |
| * | K090752 | Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator…Summary page 5…vice Classification Class II Penumbra System Max (K113163) Predicate Devices Penumbra Reperfusion Catheter 054 (K090752) Penumbra System ACE 68 Reperfusion Catheter (K161640) Device Description The Zenith Aspir… | 2009 |
| * | K161640 | Penumbra System ACE 68 Reperfusion CatheterSummary page 5…(K113163) Predicate Devices Penumbra Reperfusion Catheter 054 (K090752) Penumbra System ACE 68 Reperfusion Catheter (K161640) Device Description The Zenith Aspiration Catheter is a single-lumen, variable stiffness catheter. The device has a hydrophil… | 2016 |
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 3 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 6 other devices also cite its predicate K113163.
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 Zenith Aspiration Catheter, with the Disposable Aspiration Tubing 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Disposable Aspiration Tubing Set is indicated to connect the Zenith Aspiration Catheter to a compatible aspiration pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252707: Zenith Aspiration Catheter; Disposable Aspiration Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252707
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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