Cleared Traditional

K250264 - SugarBug (1.x) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250264 · Bench7, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
282d
Days
Class 2
Risk

K250264 is an FDA 510(k) clearance for the SugarBug (1.x). Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Bench7, Inc. (Bismarck, US). The FDA issued a Cleared decision on November 7, 2025 after a review of 282 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bench7, Inc. devices

Submission Details

510(k) Number K250264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 107d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - 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
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 Radiology devices follow this clearance model.

Regulatory Consultant

Highland Biomedical, Inc.
Adam Heroux

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 - MYN Analyzer, Medical Image

All 35
Devices cleared under the same product code (MYN) and FDA review panel - the closest regulatory comparables to K250264.
qXR-Detect
K251934 · Qure.Ai Technologies · Jan 2026
Diagnocat
K252934 · DGNCT, LLC · Jan 2026
DS Core Detect
K253009 · Dentsply Sirona, Inc. · Jan 2026
DTX Studio Assist
K252086 · Nobel Biocare C/O Medicim NV · Nov 2025
Second Opinion® Panoramic
K250525 · Pearl, Inc. · Nov 2025
Videa Dental AI
K251002 · Videahealth, Inc. · Sep 2025