510(k) · Cleared
Recalled · Class II · 2019Zenith 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 Apr 19, 2018 as substantially equivalent to K161064 (Penumbra, Inc., 2016) after a 275-day review. Its family tree reaches back 9 generations to 2001. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 19, 2018
- Review
- 275 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003410 (2001). 12 ancestors in all, the oldest K003086 (2001). 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 1 generation backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- This deviceK172167 Zenith Flex SystemInneuroco, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK181354 074 Zenith Flex SystemInneuroco, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK190212 AXS Vecta Aspiration SystemStryker Neurovascular · 2019
- Descendant · 3 generations on · 4 of its ownK191768 AXS Vecta Aspiration SystemStryker Neurovascular · 2019
- Descendant · 4 generations on · 2 of its ownK243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2025
- Descendant · 5 generations on · 1 of its ownK253590 Millipede SystemPerfuze, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 7 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 6 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 5 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 4 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 1 generation backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- This deviceK172167 Zenith Flex SystemInneuroco, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181354074 Zenith Flex SystemInneuroco, Inc. · 2018 · cites it directly6descendants
- K190212AXS Vecta Aspiration SystemStryker Neurovascular · 2019 · 2 generations on5descendants
- K191768AXS Vecta Aspiration SystemStryker Neurovascular · 2019 · 3 generations on4descendants
- K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2025 · 4 generations on2descendants
- K253590Millipede SystemPerfuze, Ltd. · 2026 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −8 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −7 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −6 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −5 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −4 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −3 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −2 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −1 | K161064 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K172167 | Zenith Flex System | Inneuroco, Inc. | 2018 | — |
| +1 | K181354 | 074 Zenith Flex System | Inneuroco, Inc. | 2018 | 1 |
| +2 | K190212 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 | — |
| +3 | K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 | — |
| +4 | K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2025 | — |
| +5 | K253590 | Millipede System | Perfuze, Ltd. | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161064 | Penumbra System ACE 68 Reperfusion CatheterSummary page 5…510(k) Number Penumbra System ACE 68 Penumbra, Inc K161064 Reperfusion Catheter Device Description The Zenith Flex System consists of the Zenith Flex Catheter, th… | 2016 |
| † | K171672 | 065 Zenith, 074 Zenith | 2017 |
| † | K152202 | Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm | 2015 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181354 | 074 Zenith Flex System | 2018 | 6 |
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-1620-2020 | 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.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K181354 (Inneuroco, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K161064.
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/K172167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172167: 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/K172167
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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