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FDA 510(k)

Orchid Safety Release Valve

K-Number: K230266 · 2023-05-04

Decision Date2023-05-04
Product CodeQOI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orchid Safety Release Valve 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 2023-05-04 under 510(k) number K230266. 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?

Orchid Safety Release Valve is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Linear Health Sciences, LLC. The 510(k) number is K230266.

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

Orchid Safety Release Valve received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230266.

Who is the listed applicant for Orchid Safety Release Valve?

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?

The FDA product code for Orchid Safety Release Valve 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.