510(k) · Cleared
Recalled · Class I · 2020Penumbra System Penumbra JET 7X
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 Feb 27, 2020 as substantially equivalent to K190010 (Penumbra, Inc., 2019) after a 220-day review. Its family tree reaches back 12 generations to 2001. 5 of the 20 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Feb 27, 2020
- Review
- 220 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 4 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003410 (2001). 17 ancestors in all, the oldest K003086 (2001). 2 later devices descend from it, 2 citing it directly. 5 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- 2 generations backK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- 1 generation backK190010 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · Recalled (Class I)
- This deviceK191946 Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK222786 072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK202251 Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex…Penumbra, Inc. · 2020 · Recalled (Class I)
Show all 12 generations
- Root · 12 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 11 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 10 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 9 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 8 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 7 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 6 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 5 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 4 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- 3 generations backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- 2 generations backK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- 1 generation backK190010 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · Recalled (Class I)
- This deviceK191946 Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −11 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −10 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −9 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −8 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −7 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −6 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −5 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −4 | K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016 | — |
| −3 | K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| −2 | K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2018 | — |
| −1 | K190010 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2019 | Class I |
| 0 (this device) | K191946 | Penumbra System Penumbra JET 7X | Penumbra, Inc. | 2020 | — |
| +1 | K222786 | 072 Aspiration System | Q'Apel Medical, Inc. | 2023 | Class I |
| +1 | K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex… | 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 |
| 2017 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
| 2023 | 1 | 1 |
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? (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 |
|---|---|---|---|
| * | K190010 | Penumbra System Reperfusion Catheter JET 7Summary page 4…Name of Manufacturer Primary Predicate Device Penumbra System® – Penumbra, Inc. K190010 cleared on June 16, 2019 Penumbra JET™ 7 Reperfusion One Penumbra Place… | 2019 |
| † | K173761 | Penumbra System Reperfusion Catheter JET 7 | 2018 |
| † | K083125 | Neuron Select Catheter Size 070 | 2008 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2020 | Class I | Z-0848-2021 | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. |
| Dec 15, 2020 | Class I | Z-0851-2021 | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. |
| Dec 15, 2020 | Class I | Z-0849-2021 | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. |
| Dec 15, 2020 | Class I | Z-0850-2021 | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. |
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 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 3 generations back · ◆ in the 2017 ancestors bar of FIG. 11 Class I recall
- K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)Penumbra, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 17 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K222786 (Q'Apel Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190010.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K191946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191946: Penumbra System Penumbra JET 7X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191946
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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