Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

88 results for "Penumbra, Inc."
1–24 of 88
Search insights Median review: 89d Cleared: 100% Top manufacturer: Penumbra, Inc. Lead specialty: Neurology
Cleared CT Oct 15, 2026
INDIGO® Aspiration System
K262904 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared CT Jun 10, 2026
Penumbra System (Thunderbolt Aspiration Tubing)
K250690 · NRY
Penumbra, Inc.
Neurology · 460d
Cleared Apr 24, 2026
INDIGO® Aspiration System – INDIGO Link
K260599 · QEW
Penumbra, Inc.
Cardiovascular · 59d
Cleared Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW
Penumbra, Inc.
Cardiovascular · 225d
Cleared Oct 16, 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
K252612 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared Mar 14, 2025
Ruby XL System
K250079 · KRD
Penumbra, Inc.
Cardiovascular · 60d
Cleared Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
K242104 · NRY
Penumbra, Inc.
Neurology · 210d
Cleared Dec 11, 2024
Access25™ Delivery Microcatheter
K242033 · QJP
Penumbra, Inc.
Neurology · 153d
Cleared Nov 20, 2024
Element Vascular Access System
K242520 · DYB
Penumbra, Inc.
Cardiovascular · 89d
Cleared Sep 25, 2024
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K242075 · QEW
Penumbra, Inc.
Cardiovascular · 71d
Cleared Sep 03, 2024
Indigo® Aspiration System – Aspiration Catheter 6X
K242319 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Jun 10, 2024
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
K241399 · QEW
Penumbra, Inc.
Cardiovascular · 25d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · QJP
Penumbra, Inc.
Neurology · 181d
Cleared Feb 02, 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2023
Penumbra LP Coil System
K230284 · HCG
Penumbra, Inc.
Neurology · 265d
Cleared Feb 13, 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · QEW
Penumbra, Inc.
Cardiovascular · 124d
Cleared Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
K222808 · NRY
Penumbra, Inc.
Neurology · 95d
Cleared Dec 20, 2022
Indigo Aspiration System - Lightning Flash
K222358 · QEW
Penumbra, Inc.
Cardiovascular · 138d
Cleared Nov 04, 2022
BENCHMARK BMX81 Access System
K221822 · QJP
Penumbra, Inc.
Neurology · 134d
Cleared Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · QEW
Penumbra, Inc.
Cardiovascular · 210d
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390 · QJP
Penumbra, Inc.
Neurology · 307d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838 · QJP
Penumbra, Inc.
Neurology · 262d
Cleared Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654 · NRY
Penumbra, Inc.
Neurology · 80d
Cleared Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
K211411 · NRY
Penumbra, Inc.
Neurology · 56d