Cleared Special

Green Card Bowie-Dick Test (BD115)

K250172 · Steritec Products, Inc. (A Getinge Company) · General Hospital

Feb 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250172 is an FDA 510(k) clearance for the Green Card Bowie-Dick Test (BD115), a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Steritec Products, Inc. (A Getinge Company) (Engelwood, US). The FDA issued a Cleared decision on February 20, 2025, 30 days after receiving the submission on January 21, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K250172 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2025
Decision Date	February 20, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF