Cleared Traditional

K250690 - Penumbra System (Thunderbolt Aspiration...

K250690 is an FDA 510(k) clearance for Penumbra System (Thunderbolt Aspiration..., manufactured by Penumbra, Inc.. The device is a Class 2 Neurology device with product code NRY cleared through the Traditional 510(k) pathway after a 460-day FDA review.

K250690 · Penumbra, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
460d
Days
Class 2
Risk

K250690 is an FDA 510(k) clearance for the Penumbra System (Thunderbolt Aspiration Tubing). Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on June 10, 2026 after a review of 460 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Penumbra, Inc. devices

FDA 510(k) Submission Details - K250690

510(k) Number K250690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2025
Decision Date June 10, 2026
Days to Decision 460 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
312d slower than avg
Panel avg: 148d · This submission: 460d
Pathway characteristics
Predicate-based equivalence.

NRY Device Classification - Class 2, Special Controls

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05437055 Completed Interventional Industry-sponsored

THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing

216
Patients (actual)
32
Sites
Treatment
Purpose
Open label
Masking
Condition studied Acute Ischemic Stroke; Large Vessel Occlusion
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Donald Frei, M.D.
Sponsor Penumbra Inc. (industry)
Started 2022-08-11 → Primary completion 2024-09-23 → Completed 2024-12-10
Primary outcome
Efficacy Endpoint: Angiographic Revascularization
Secondary outcome
Efficacy Endpoint: Angiographic Revascularization After First Pass
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 106
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K250690.
Zenith Aspiration Catheter
K252707 · Suzhou Zenith Vascular SciTech Limited · May 2026
Lynx Aspiration Catheter System
K254276 · Q'Apel Medical, Inc. · May 2026
Millipede System
K253590 · Perfuze, Ltd. · Mar 2026
Tigertriever 25 Revascularization Device
K253062 · Rapid Medical , Ltd. · Mar 2026
Esperance pHLO Aspiration System
K251357 · Phenox, Ltd. · Jan 2026
NeVasc Aspiration System
K251006 · Vesalio, Inc. · Nov 2025