510(k) · Cleared
ClearedPenumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054
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 May 21, 2010 as substantially equivalent to K090752 (Penumbra, Inc., 2009) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 2001. 6 of the 125 devices in its family, counting itself, have a Class I recall. 118 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003410 (2001). 6 ancestors in all, the oldest K003086 (2001). 118 later devices descend from it, 4 citing it directly. 6 of the 125 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 3 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 2 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 1 generation backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- This deviceK100769 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
- Descendant · cites it directly · 43 of its ownK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 118 · See all- 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
- K121917Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012 · cites it directly43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −3 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −2 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −1 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| 0 (this device) | 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 | — |
| +1 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 12 | 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 |
|---|---|---|---|
| * | K090752 | Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator…Summary page 2…SeprtrFe [026, 032, ~041, 054~1 [026, 032, 041,054! 510(k) NO. K072718 & K090752 To be determined Classification Class II, NRY… | 2009 |
| * | K072718 | Penumbra SystemSummary page 1…054, Penumbra Separator 054 Penumbra, Inc. K072718 / 28 Dec 2007 Penumbra System [026, 032, 041]… | 2007 |
What descends from it? (118)
See all 1184 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K113163 (Penumbra, Inc., 2011) has gone furthest, with 116 descendants of its own.
- 10 other devices also cite its predicate K090752.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 (in 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/K100769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100769: Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100769
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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