FDA 510(k)

Steam-Dot Process Indicator

K-Number: K210553 · 2021-05-19

ApplicantPropper Manufacturing Co., Inc.

Decision Date2021-05-19

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Steam-Dot Process Indicator is a medical device manufactured by Propper Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2021-05-19 under approval number K210553. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steam-Dot Process Indicator?

Steam-Dot Process Indicator is a medical device that received FDA 510(k) clearance on 2021-05-19. It is manufactured by Propper Manufacturing Co., Inc.. The 510(k) number is K210553.

When was Steam-Dot Process Indicator approved by the FDA?

Steam-Dot Process Indicator received FDA 510(k) clearance on 2021-05-19, under approval number K210553.

What company makes Steam-Dot Process Indicator?

Steam-Dot Process Indicator is manufactured by Propper Manufacturing Co., Inc..

What is the FDA product code for Steam-Dot Process Indicator?

The FDA product code for Steam-Dot Process Indicator is JOJ.

Other Devices by Propper Manufacturing Co., Inc.

K210866Steri-Dot Process Indicator K222137OK Plus Indicator K212592Gas-Chex Indicator K240910EO Chex Indicator Tape K250306Chex-All Sterilization Pouches and Tubes

Related Devices (Code: JOJ)

K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeCanadian Technical Tape, Ltd. K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation K152630VERIFY STEAM Integrating IndicatorSTERIS Corporation K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation K170439AN87 DosimeterAndersen Sterilizers, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.