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FDA 510(k)

Orchid Safety Release Valve(TM)

K-Number: K212064 · 2022-05-03

Decision Date2022-05-03
Product CodeQOI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orchid Safety Release Valve(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Linear Health Sciences, LLC. It received FDA 510(k) clearance on 2022-05-03 under 510(k) number K212064. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orchid Safety Release Valve(TM)?

Orchid Safety Release Valve(TM) is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Linear Health Sciences, LLC. The 510(k) number is K212064.

When did Orchid Safety Release Valve(TM) receive FDA 510(k) clearance?

Orchid Safety Release Valve(TM) received FDA 510(k) clearance on 2022-05-03, under 510(k) number K212064.

Who is the listed applicant for Orchid Safety Release Valve(TM)?

The FDA 510(k) record lists Linear Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orchid Safety Release Valve(TM)?

The FDA product code for Orchid Safety Release Valve(TM) is QOI.

Other records listing Linear Health Sciences, LLC 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.

Related Devices (Code: QOI)

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.

Official Source

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