510(k) · Cleared
ClearedPenumbra System Reperfusion Catheter JET 7
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 Aug 17, 2018 as substantially equivalent to K161640 (Penumbra, Inc., 2016) and 1 other predicate after a 249-day review. Its family tree reaches back 10 generations to 2001. 5 of the 26 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Aug 17, 2018
- Review
- 249 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K003410 (2001). 15 ancestors in all, the oldest K003086 (2001). 10 later devices descend from it, 3 citing it directly. 5 of the 26 devices in this family, counting this one, have a Class I recall.
- 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 deviceK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK211654 Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK190010 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK191946 Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK242104 Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK182522 Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc. · 2018
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 deviceK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2021 · cites it directly3descendants
- K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · cites it directly3descendants
- K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 2 generations on2descendants
- K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc. · 2025 · 2 generations on1descendant
- K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc. · 2018 · cites it directly1descendant
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) | K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2018 | — |
| +1 | K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2021 | — |
| +1 | K190010 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2019 | Class I |
| +2 | K191946 | Penumbra System Penumbra JET 7X | Penumbra, Inc. | 2020 | Class I |
| +2 | K242104 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2025 | — |
| +1 | K182522 | Penumbra System (Modified 110 Aspiration Tubing) | Penumbra, Inc. | 2018 | — |
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 |
| 2017 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 2 |
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
5 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? (2)
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 |
|---|---|---|---|
| * | K161640 | Penumbra System ACE 68 Reperfusion CatheterSummary page 4…al) 1.6 Predicate Devices 510(k) Number / Clearance Date Name of Device Name of Manufacturer Primary Predicate Device K161640 cleared on July 12, 2016 Penumbra System – ACE 68 Penumbra, Inc. Rep… | 2016 |
| * | K162901 | Penumbra 3D Revascularization DeviceSummary page 4…One Penumbra Place Alameda, CA 94502 USA Additional Predicate Device K162901 (applicable for indication Penumbra System – 3D Penumbra, Inc. only) cleared on April 20, 2017 Revas… | 2017 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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.
- K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 11 Class I recall
- K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
- K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 2 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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211654 (Penumbra, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K161640.
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?
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. Patients who are ineligible for intravenous tissue plasminogen…
Read the full statement (195 words)
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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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 Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173761: Penumbra System Reperfusion Catheter JET 7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173761
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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