510(k) · Cleared
Recalled · Class II · 2019074 Zenith Flex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inneuroco, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Oct 25, 2018 as substantially equivalent to K172167 (Inneuroco, Inc., 2018) after a 156-day review. Its family tree reaches back 10 generations to 2001. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 25, 2018
- Review
- 156 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003410 (2001). 13 ancestors in all, the oldest K003086 (2001). 6 later devices descend from it, 1 citing it directly.
- 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 backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- 1 generation backK172167 Zenith Flex SystemInneuroco, Inc. · 2018 · Recalled
- This deviceK181354 074 Zenith Flex SystemInneuroco, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK190212 AXS Vecta Aspiration SystemStryker Neurovascular · 2019
- Descendant · 2 generations on · 4 of its ownK191768 AXS Vecta Aspiration SystemStryker Neurovascular · 2019
- Descendant · 3 generations on · 2 of its ownK243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK253590 Millipede SystemPerfuze, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK261089 Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter…Maduro Medical, Inc. · 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 backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- 1 generation backK172167 Zenith Flex SystemInneuroco, Inc. · 2018 · Recalled
- This deviceK181354 074 Zenith Flex SystemInneuroco, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190212AXS Vecta Aspiration SystemStryker Neurovascular · 2019 · cites it directly5descendants
- K191768AXS Vecta Aspiration SystemStryker Neurovascular · 2019 · 2 generations on4descendants
- K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2025 · 3 generations on2descendants
- K253590Millipede SystemPerfuze, Ltd. · 2026 · 4 generations on1descendant
- K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration…Maduro Medical, Inc. · 2026 · 3 generations on0descendants
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 | K161064 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| −1 | K172167 | Zenith Flex System | Inneuroco, Inc. | 2018 | 1 |
| 0 (this device) | K181354 | 074 Zenith Flex System | Inneuroco, Inc. | 2018 | — |
| +1 | K190212 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 | — |
| +2 | K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 | — |
| +3 | K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2025 | — |
| +4 | K253590 | Millipede System | Perfuze, Ltd. | 2026 | — |
| +3 | K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical… | Maduro Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190212 | AXS Vecta Aspiration System | 2019 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2019 | Class II | Z-1621-2020 | Component design/selection | The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K190212 (Stryker Neurovascular, 2019) has gone furthest, with 5 descendants 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. 2018, 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 Flex System, including the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated 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 failed IV t-PA therapy are candidates for treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181354: 074 Zenith Flex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181354
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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