Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Gas-Chex Indicator

K-Number: K212592 · 2022-01-20

ApplicantPropper Manufacturing Co., Inc.
Decision Date2022-01-20
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Gas-Chex Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Propper Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212592. 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 Gas-Chex Indicator?

Gas-Chex Indicator is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Propper Manufacturing Co., Inc.. The 510(k) number is K212592.

When did Gas-Chex Indicator receive FDA 510(k) clearance?

Gas-Chex Indicator received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212592.

Who is the listed applicant for Gas-Chex Indicator?

The FDA 510(k) record lists Propper Manufacturing Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gas-Chex Indicator?

The FDA product code for Gas-Chex Indicator is JOJ.

Other records listing Propper Manufacturing Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250306Chex-All Sterilization Pouches and TubesK240910EO Chex Indicator TapeK222137OK Plus IndicatorK210866Steri-Dot Process IndicatorK210553Steam-Dot Process Indicator

Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

Official Source

View on FDA Database →

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

↑