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FDA 510(k)

Orchid Safety Release ValveTM

K-Number: K232094 · 2023-10-03

ApplicantLinear Health Sciences, LLC
Decision Date2023-10-03
Product CodeQOI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orchid Safety Release ValveTM is a medical device manufactured by Linear Health Sciences, LLC. It received FDA 510(k) clearance on 2023-10-03 under approval number K232094. 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 ValveTM?

Orchid Safety Release ValveTM is a medical device that received FDA 510(k) clearance on 2023-10-03. It is manufactured by Linear Health Sciences, LLC. The 510(k) number is K232094.

When was Orchid Safety Release ValveTM approved by the FDA?

Orchid Safety Release ValveTM received FDA 510(k) clearance on 2023-10-03, under approval number K232094.

What company makes Orchid Safety Release ValveTM?

Orchid Safety Release ValveTM is manufactured by Linear Health Sciences, LLC.

What is the FDA product code for Orchid Safety Release ValveTM?

The FDA product code for Orchid Safety Release ValveTM is QOI.

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Related PubMed Literature

PMID: 41436092 Comprehensive Evaluation of the Embryotoxicity and Ototoxicity of a Car Diffuser on Zebrafish Larvae: Impacts on Morphology and Hair Cells. Journal of applied toxicology : JAT (2025) PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

Other Devices by Linear Health Sciences, LLC

K212064Orchid Safety Release Valve(TM) K230266Orchid Safety Release Valve K241415Orchid Safety Release Valve™

Related Devices (Code: QOI)

DEN190043SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical K222791SafeBreak VascularLineus Medical, LLC K212064Orchid Safety Release Valve(TM)Linear Health Sciences, LLC K231957SafeBreak® VascularLineus Medical K223486SafeBreak® VascularLineus Medical K230266Orchid Safety Release ValveLinear Health Sciences, LLC

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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