Cleared Abbreviated

Steri-Dot Process Indicator

K210866 · Propper Manufacturing Co., Inc. · General Hospital
Jun 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K210866 is an FDA 510(k) clearance for the Steri-Dot Process Indicator, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on June 21, 2021, 90 days after receiving the submission on March 23, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K210866 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2021
Decision Date June 21, 2021
Days to Decision 90 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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