510(k) · Cleared
ClearedPenumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054
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 Sep 21, 2009 after a 185-day review. The FDA summary names its predicate without a number. 6 of the 122 devices in its family, counting itself, have a Class I recall. 121 later devices descend from it.
- Decided
- Sep 21, 2009
- Review
- 185 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 0
121 later devices descend from it, 11 citing it directly. 6 of the 122 devices in this family, counting this one, have a Class I recall.
- This deviceK090752 Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054…Penumbra, Inc. · 2009
- Descendant · cites it directly · 118 of its ownK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- Descendant · cites it directly · 116 of its ownK113163 Penumbra System MaxPenumbra, Inc. · 2011
- Descendant · cites it directly · 61 of its ownK133317 Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014
- Descendant · cites it directly · 60 of its ownK142458 Penumbra System ACEPenumbra, Inc. · 2015
- Descendant · 2 generations on · 54 of its ownK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 121 · See all- K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc. · 2010 · cites it directly118descendants
- K113163Penumbra System MaxPenumbra, Inc. · 2011 · cites it directly116descendants
- K133317Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014 · cites it directly61descendants
- K142458Penumbra System ACEPenumbra, Inc. · 2015 · cites it directly60descendants
- K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016 · 2 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090752 | Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra… | Penumbra, Inc. | 2009 | — |
| +1 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| +1 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| +1 | K133317 | Penumbra System / Penumbra System Max | Penumbra, Inc. | 2014 | — |
| +1 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| +2 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 1 |
| 2018 | 13 | 0 |
| 2019 | 7 | 1 |
| 2020 | 10 | 2 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 2 |
| 2024 | 13 | 0 |
| 2025 | 18 | 0 |
| 2026 | 18 | 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.
6 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 |
|---|---|---|---|
| * | — | Penumbra System Named without a submission number | |
| * | — | Neuro Intracranial Access System Named without a submission number |
What descends from it? (121)
See all 12111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 | 2010 | 118 |
| K113163 | Penumbra System Max | 2011 | 116 |
| K133317 | Penumbra System / Penumbra System Max | 2014 | 61 |
| K142458 | Penumbra System ACE | 2015 | 60 |
| K121917 | Penumbra Embolectomy Aspiration System | 2012 | 43 |
| K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058… | 2018 | 6 |
| K093970 | Pica Catheter | 2010 | 5 |
| K122772 | Penumbra DDC Catheters | 2012 | 4 |
| K211697 | Esperance Aspiration Catheter System | 2021 | 1 |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | 2026 | 0 |
Has anything in its family been recalled? (6 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
- K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 7 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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K100769 (Penumbra, Inc., 2010) has gone furthest, with 118 descendants of its own.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SystemTM 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/K090752 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090752
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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