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

FDA 510(k)

Orchid Safety Release Valve(TM)

K-Number: K212064 · 2022-05-03

ApplicantLinear Health Sciences, LLC
Decision Date2022-05-03
Product CodeQOI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orchid Safety Release Valve(TM) is a medical device manufactured by Linear Health Sciences, LLC. It received FDA 510(k) clearance on 2022-05-03 under approval 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. It is manufactured by Linear Health Sciences, LLC. The 510(k) number is K212064.

When was Orchid Safety Release Valve(TM) approved by the FDA?

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

What company makes Orchid Safety Release Valve(TM)?

Orchid Safety Release Valve(TM) is manufactured by Linear Health Sciences, LLC.

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

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

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT04818502 Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation ACTIVE_NOT_RECRUITING NCT06777368 REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT07605624 Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease NOT_YET_RECRUITING NCT07193888 Navitor Japan Study RECRUITING

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) PMID: 40278172 A Narrative Review of the Evidence for Transcatheter Aortic Valve Implants. Journal of cardiovascular development and disease (2025)

Other Devices by Linear Health Sciences, LLC

K232094Orchid Safety Release ValveTM 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 K232094Orchid Safety Release ValveTMLinear 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.

↑