Cleared Special

K252213 - Bendit17 Microcatheter (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252213 · Bend IT Technologies, Ltd. · Neurology device
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Dec 2025
Decision
141d
Days
Class 2
Risk

K252213 is an FDA 510(k) clearance for the Bendit17 Microcatheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Bend IT Technologies, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on December 3, 2025 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bend IT Technologies, Ltd. devices

Submission Details

510(k) Number K252213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2025
Decision Date December 03, 2025
Days to Decision 141 days
Submission Type Special
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
7d faster than avg
Panel avg: 148d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Heyer Regulatory Solutions
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

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