Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Penumbra, Inc. — Predicate Candidate Screening

87 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

94 daysmedian FDA review time

225 days90th percentile

87clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250690	Penumbra System (Thunderbolt Aspiration Tubing)	Penumbra, Inc.	2026-06-10	460	0
K260599	INDIGO® Aspiration System – INDIGO Link	Penumbra, Inc.	2026-04-24	59	0
K251949	INDIGO® Aspiration System - Lightning Flash Aspiration Tubin	Penumbra, Inc.	2026-02-05	225	0
K252612	INDIGO® Aspiration System – Lightning Flash Aspiration Tubin	Penumbra, Inc.	2025-10-16	58	0
K250079	Ruby XL System	Penumbra, Inc.	2025-03-14	60	0
K242104	Penumbra System (Reperfusion Catheter RED 72)	Penumbra, Inc.	2025-02-13	210	0
K242033	Access25™ Delivery Microcatheter	Penumbra, Inc.	2024-12-11	153	0
K242520	Element Vascular Access System	Penumbra, Inc.	2024-11-20	89	0
K242075	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	Penumbra, Inc.	2024-09-25	71	0
K242319	Indigo® Aspiration System – Aspiration Catheter 6X	Penumbra, Inc.	2024-09-03	29	0
K241399	Indigo® Lightning Flash Aspiration System – Select +™ Cathet	Penumbra, Inc.	2024-06-10	25	0
K233201	MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWA	Penumbra, Inc.	2024-03-27	181	0
K240030	Indigo® Aspiration System - Lightning® Flash	Penumbra, Inc.	2024-02-02	29	0
K230284	Penumbra LP Coil System	Penumbra, Inc.	2023-10-25	265	0
K223186	Indigo® Aspiration System – Lightning Bolt Aspiration Tubing	Penumbra, Inc.	2023-02-13	124	0
K222358	Indigo Aspiration System - Lightning Flash	Penumbra, Inc.	2022-12-20	138	0
K222808	Penumbra System (Reperfusion Catheter RED 43)	Penumbra, Inc.	2022-12-20	95	0
K221822	BENCHMARK BMX81 Access System	Penumbra, Inc.	2022-11-04	134	0
K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Sep	Penumbra, Inc.	2022-10-04	210	0
K213390	Benchmark BMX96 Access System	Penumbra, Inc.	2022-08-18	307	0
K212838	Benchmark Intracranial Access System	Penumbra, Inc.	2022-05-27	262	0
K211654	Penumbra System (Reperfusion Catheter RED 72)	Penumbra, Inc.	2021-08-16	80	0
K211411	Penumbra System (RED 68 Reperfusion Catheter)	Penumbra, Inc.	2021-07-01	56	1
K203440	Penumbra System (Reperfusion Catheter RED 62)	Penumbra, Inc.	2021-05-20	178	0
K210323	Indigo Aspiration System - Lightning Aspiration Tubing	Penumbra, Inc.	2021-02-26	22	0
K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration Syste	Penumbra, Inc.	2021-02-09	28	0
K202821	Indigo Aspiration System - Aspiration Catheter 12 and Separa	Penumbra, Inc.	2020-11-18	55	0
K202251	Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xt	Penumbra, Inc.	2020-08-31	21	4
K193595	Indigo Aspiration System - Aspiration Catheter 7 and Separat	Penumbra, Inc.	2020-08-19	240	0
K201271	Benchmark BMX96 Access System	Penumbra, Inc.	2020-06-11	30	0
K192981	Indigo System Aspiration Catheter 12, Indigo Aspiration Syst	Penumbra, Inc.	2020-05-28	217	0
K200771	Indigo Aspiration System Lightning Aspiration Tubing	Penumbra, Inc.	2020-04-22	28	0
K193244	Indigo Aspiration System – Lightning Aspiration Tubing	Penumbra, Inc.	2020-03-13	109	0
K191946	Penumbra System Penumbra JET 7X	Penumbra, Inc.	2020-02-27	220	4
K192833	Indigo Aspiration System	Penumbra, Inc.	2019-12-20	79	0
K192955	Penumbra LP Coil System	Penumbra, Inc.	2019-11-20	30	0
K190719	Artemis Eye System	Penumbra, Inc.	2019-08-30	163	0
K190010	Penumbra System Reperfusion Catheter JET 7	Penumbra, Inc.	2019-06-16	164	4
K190464	Penumbra System 3D Revascularization Device	Penumbra, Inc.	2019-04-26	59	0
K183296	REAL Immersive System	Penumbra, Inc.	2019-03-18	111	0
K182522	Penumbra System (Modified 110 Aspiration Tubing)	Penumbra, Inc.	2018-10-12	29	0
K173761	Penumbra System Reperfusion Catheter JET 7	Penumbra, Inc.	2018-08-17	249	0
K180008	Penumbra System	Penumbra, Inc.	2018-06-20	169	0
K180412	Indigo Aspiration System (CAT RX and Separator 4)- Penumbra	Penumbra, Inc.	2018-05-15	89	0
K180939	Indigo Aspiration System - Modified 110 Aspiration Tubing	Penumbra, Inc.	2018-05-03	23	0
K173614	Penumbra Coil 400, Ruby Coil System, POD System	Penumbra, Inc.	2018-04-17	146	0
K180105	Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspi	Penumbra, Inc.	2018-03-08	51	0
K171332	Artemis Neuro Evacuation Device	Penumbra, Inc.	2017-08-14	98	0
K170852	POD Packing Coil	Penumbra, Inc.	2017-07-19	119	0
K163618	INDIGO Aspiration System	Penumbra, Inc.	2017-05-24	153	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda