510(k) · Cleared

Cleared

Penumbra System / Penumbra System Max

K133317510(k) TraditionalCleared May 13, 2014197-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Penumbra, Inc. · NRY Catheter, Thrombus Retriever

Cleared on May 13, 2014 as substantially equivalent to K072718 (Penumbra, Inc., 2007) and 2 other predicates after a 197-day review. Its family tree reaches back 5 generations to 2001. 6 of the 69 devices in its family, counting itself, have a Class I recall. 61 later devices descend from it.

Decided: May 13, 2014
Review: 197 days
Class: Class II
Product code: NRY
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K003410 (2001). 7 ancestors in all, the oldest K003086 (2001). 61 later devices descend from it, 2 citing it directly. 6 of the 69 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
4 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
3 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
2 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
1 generation backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
This deviceK133317 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 · 3 generations on · 31 of its ownK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
Descendant · 4 generations on · 17 of its ownK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
Descendant · 4 generations on · 16 of its ownK162901 Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · Recalled (Class I)

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2015high 10 (2018) · low 1 (2022)2026

Class I recalls in this family

K162901 Penumbra 3D Revascularization Device4 generations on · 2017
K223530 Route 92 Medical Full Length 070 Reperfusion…4 generations on · 2023
K190010 Penumbra System Reperfusion Catheter JET 76 generations on · 2019
K191946 Penumbra System Penumbra JET 7X7 generations on · 2020

Most influential descendants

Showing 5 of 61 · See all

K142458Penumbra System ACEPenumbra, Inc. · 2015 · cites it directly60descendants
K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016 · 2 generations on54descendants
K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016 · 3 generations on31descendants
K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016 · 4 generations on17descendants
K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 4 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K003410	Concentric Retriever, Model 90030	Concentric Medical, Inc.	2001	1
−4	K030476	Modified Concentric Retriever, Model 90037	Concentric Medical, Inc.	2003	2
−3	K033736	Merci Retriever, Models 90065, 90066	Concentric Medical, Inc.	2004	—
−2	K072718	Penumbra System	Penumbra, Inc.	2007	1
−1	K100769	Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…	Penumbra, Inc.	2010	—
0 (this device)	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	—
+3	K160449	Penumbra System, Penumbra Pump MAX	Penumbra, Inc.	2016	—
+4	K161640	Penumbra System ACE 68 Reperfusion Catheter	Penumbra, Inc.	2016	—
+4	K162901	Penumbra 3D Revascularization Device	Penumbra, Inc.	2017	Class I

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
2015	2	0
2016	4	0
2017	2	1
2018	10	0
2019	5	1
2020	4	2
2021	4	0
2022	1	0
2023	6	2
2024	4	0
2025	9	0
2026	10	0

FIG. 1 — Lineage of K133317, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K072718	Penumbra System Summary page 1 …510O(k) Number Naeo/rdiaeDvc Name of Clearance Date Naeo rdct eieManufacturer K072718 [28Dec2007] Penumbra System [026, 032, 041] Penumbra, Inc. K090752 [21 Sep2009] Penumbra S…	Penumbra, Inc.	2007	1
*	K090752	Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator… Summary page 1 …Clearance Date Naeo rdct eieManufacturer K072718 [28Dec2007] Penumbra System [026, 032, 041] Penumbra, Inc. K090752 [21 Sep2009] Penumbra System [054] Penumbra, Inc. K 100769 [21May20 10] Penumbra S…	Penumbra, Inc.	2009	—
*	K100769	Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 Summary page 1 …ec2007] Penumbra System [026, 032, 041] Penumbra, Inc. K090752 [21 Sep2009] Penumbra System [054] Penumbra, Inc. K 100769 [21May20 10] Penumbra System Separator Flex PnmrIc __________________[026, 032, 041, 054]…	Penumbra, Inc.	2010	—
Kept off the family tree	K113163	FDA’s K113163 is Penumbra System Max Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Penumbra, Inc.	2011	—

Also cleared against K072718: 6 other devices →

What descends from it? (61)

See all 61

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142458	Penumbra System ACE	Penumbra, Inc.	2015	60
K151623	Penumbra System 110 Aspiration Tubing	Penumbra, Inc.	2015	2

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 13 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
3 of the 7 ancestors have a recall of any class.
Of its descendants, K142458 (Penumbra, Inc., 2015) has gone furthest, with 60 descendants of its own.
6 other devices also cite its predicate K072718.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NRY

15in 2025

2007high 15 (2025) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRY

129in 2025

2007high 185 (2017) · low 75 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NRY

4in 2020

2007high 4 (2017) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · NRY

565in 2025

2007high 711 (2023) · low 13 (2007)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 / Penumbra System MAX are 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/K133317 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133317: Penumbra System / Penumbra System Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133317

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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