510(k) · Cleared
ClearedPenumbra System ACE 68 Reperfusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Jun 12, 2016 as substantially equivalent to K152541 (Penumbra, Inc., 2016) after a 58-day review. Its family tree reaches back 8 generations to 2001. 1 of the 27 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Jun 12, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003410 (2001). 11 ancestors in all, the oldest K003086 (2001). 15 later devices descend from it, 5 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 6 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 5 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 4 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 3 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 2 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 1 generation backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- This deviceK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK172167 Zenith Flex SystemInneuroco, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 6 of its ownK181354 074 Zenith Flex SystemInneuroco, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 5 of its ownK190212 AXS Vecta Aspiration SystemStryker Neurovascular · 2019
- Descendant · 4 generations on · 4 of its ownK191768 AXS Vecta Aspiration SystemStryker Neurovascular · 2019
- Descendant · cites it directly · 3 of its ownK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223530 Route 92 Medical Full Length 070 Reperfusion…cites it directly · 2023
Most influential descendants
Showing 5 of 15 · See all- K172167Zenith Flex SystemInneuroco, Inc. · 2018 · cites it directly7descendants
- K181354074 Zenith Flex SystemInneuroco, Inc. · 2018 · 2 generations on6descendants
- K190212AXS Vecta Aspiration SystemStryker Neurovascular · 2019 · 3 generations on5descendants
- K191768AXS Vecta Aspiration SystemStryker Neurovascular · 2019 · 4 generations on4descendants
- K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −6 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −5 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −4 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −3 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −2 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −1 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K161064 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| +1 | K172167 | Zenith Flex System | Inneuroco, Inc. | 2018 | 1 |
| +2 | K181354 | 074 Zenith Flex System | Inneuroco, Inc. | 2018 | 1 |
| +3 | K190212 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 | — |
| +4 | K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 | — |
| +1 | K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | 2020 | — |
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 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion CathetersSummary page 4…vice Name of Manufacturer Number Penumbra, Inc. Penumbra System® ACE™ 68 K152541 January 13, 2016 One Penumbra Place Reperfusion Catheter… | 2016 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172167 | Zenith Flex System | 2018 | 7 |
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | 2020 | 3 |
| K180705 | Riptide Aspiration System React 68 Catheter | 2018 | 1 |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set Class I | 2023 | 0 |
| K182101 | Riptide Aspiration System (React 71 Catheter) | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K172167 (Inneuroco, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K152541.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Penumbra System 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161064: Penumbra System ACE 68 Reperfusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161064
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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