Cleared Traditional

SugarBug (1.x)

K250264 · Bench7, Inc. · Radiology
Nov 2025
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K250264 is an FDA 510(k) clearance for the SugarBug (1.x), a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Bench7, Inc. (Bismarck, US). The FDA issued a Cleared decision on November 7, 2025, 282 days after receiving the submission on January 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K250264 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2025
Decision Date November 07, 2025
Days to Decision 282 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers