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FDA 510(k)

CELERITY HP Chemical Indicator

K-Number: K213262 · 2022-01-07

ApplicantSTERIS Corporation
Decision Date2022-01-07
Product CodeQKM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELERITY HP Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K213262. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELERITY HP Chemical Indicator?

CELERITY HP Chemical Indicator is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is STERIS Corporation. The 510(k) number is K213262.

When did CELERITY HP Chemical Indicator receive FDA 510(k) clearance?

CELERITY HP Chemical Indicator received FDA 510(k) clearance on 2022-01-07, under 510(k) number K213262.

Who is the listed applicant for CELERITY HP Chemical Indicator?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELERITY HP Chemical Indicator?

The FDA product code for CELERITY HP Chemical Indicator is QKM.

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Related Devices (Code: QKM)

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.

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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.

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