Cleared Traditional

BunkerHill BMD

K242295 · BunkerHill Health · Radiology
Apr 2025
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K242295 is an FDA 510(k) clearance for the BunkerHill BMD, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by BunkerHill Health (San Francisco, US). The FDA issued a Cleared decision on April 8, 2025, 249 days after receiving the submission on August 2, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K242295 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2024
Decision Date April 08, 2025
Days to Decision 249 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170