# Penumbra, Inc.

- Location (FDA's records): Alameda, CA
- FDA decisions: 88 (2005–2026): 88 510(k) clearances
- Product codes: QEW (27), NRY (25), HCG (10), DQY (10), QJP (5), GWG (4), QEX (1), KRD (1), BTA (1), JCX (1), ISD (1), LIT (1)
- 510(k) review time since 2016: median 96 days, against 89 for FDA's reviews in the same codes and years (27 of 56 faster)
- Predicates its devices cite: 135 (120 its own); citations of its devices by later devices: 191 (120 its own)
- Recalls linked to its devices: 12 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Concentric Medical, Inc.: 3 (https://510kreport.com/company/concentric-medical)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Boston Scientific, Target: 2 (https://510kreport.com/company/boston-scientific-target)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)
- Inari Medical, Inc.: 1 (https://510kreport.com/company/inari-medical)
- Mindmaze SA: 1 (https://510kreport.com/company/mindmaze)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)

## Firms that cite its devices most
- Q'Apel Medical, Inc.: 6 (https://510kreport.com/company/q-apel-medical)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular: 4 (https://510kreport.com/company/micro-therapeutics-d-b-a-ev3-neurovascular)
- Wallaby Medical: 4 (https://510kreport.com/company/wallaby-medical)
- Suzhou Zenith Vascular SciTech Limited: 4 (https://510kreport.com/company/suzhou-zenith-vascular-scitech)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- MicroVention, Inc.: 3 (https://510kreport.com/company/microvention)
- Medtronic, Ireland: 3 (https://510kreport.com/company/medtronic-ireland)
- Silk Road Medical, Inc.: 2 (https://510kreport.com/company/silk-road-medical)

## Its most-cited devices
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054 (2009), cited by 11
- K111380: Neuron Max System (2011), cited by 10
- K070970: Neuron Support Catheter System, Model 5F/6F (2007), cited by 9
- K142870: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (2015), cited by 9
- K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing (2012), cited by 8
- K072718: Penumbra System (2007), cited by 7

## Recent decisions
- K262904: INDIGO® Aspiration System (Oct 15, 2026)
- K250690: Penumbra System (Thunderbolt Aspiration Tubing) (Jun 10, 2026)
- K260599: INDIGO® Aspiration System – INDIGO Link (Apr 24, 2026)
- K251949: INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (Feb 5, 2026)
- K252612: INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (Oct 16, 2025)
- K250079: Ruby XL System (Mar 14, 2025)
- K242104: Penumbra System (Reperfusion Catheter RED 72) (Feb 13, 2025)
- K242033: Access25™ Delivery Microcatheter (Dec 11, 2024)

Source page: https://510kreport.com/company/penumbra