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 Jul 12, 2016 as substantially equivalent to K160449 (Penumbra, Inc., 2016) after a 28-day review. Its family tree reaches back 9 generations to 2001. 4 of the 31 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- Jul 12, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003410 (2001). 13 ancestors in all, the oldest K003086 (2001). 17 later devices descend from it, 6 citing it directly. 4 of the 31 devices in this family, counting this one, have a Class I recall.
- 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 backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- This deviceK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- Descendant · cites it directly · 10 of its ownK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK211654 Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK190010 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK203440 Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 2 of its ownK191946 Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · Recalled (Class I)
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 backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- This deviceK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018 · cites it directly10descendants
- K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2021 · 2 generations on3descendants
- K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 2 generations on3descendants
- K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc. · 2021 · cites it directly2descendants
- K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 3 generations on2descendants
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 | K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| +1 | K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2018 | — |
| +2 | K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2021 | — |
| +2 | K190010 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2019 | Class I |
| +1 | K203440 | Penumbra System (Reperfusion Catheter RED 62) | Penumbra, Inc. | 2021 | 1 |
| +3 | K191946 | Penumbra System Penumbra JET 7X | Penumbra, Inc. | 2020 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 1 |
| 2020 | 2 | 2 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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.
4 devices in this family have 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 |
|---|---|---|---|
| * | K160449 | Penumbra System, Penumbra Pump MAXSummary page 4…Name of Manufacturer Number Penumbra, Inc. Penumbra System and Penumbra K160449 May 25, 2016 One Penumbra Place Aspiration Pump… | 2016 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173761 | Penumbra System Reperfusion Catheter JET 7 | 2018 | 10 |
| K203440 | Penumbra System (Reperfusion Catheter RED 62) | 2021 | 2 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | 2026 | 0 |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | 2026 | 0 |
| K211411 | Penumbra System (RED 68 Reperfusion Catheter) | 2021 | 0 |
| K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | 2019 | 0 |
Has anything in its family been recalled? (4 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.
- K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
- K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)Penumbra, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 4 generations on · ◆ 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 1.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K173761 (Penumbra, Inc., 2018) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K160449.
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?
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161640: Penumbra System ACE 68 Reperfusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161640
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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