Cleared Abbreviated

OK Plus Indicator

K222137 · Propper Manufacturing Co., Inc. · General Hospital
Dec 2022
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K222137 is an FDA 510(k) clearance for the OK Plus 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 December 5, 2022, 139 days after receiving the submission on July 19, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K222137 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2022
Decision Date December 05, 2022
Days to Decision 139 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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