Orchid Safety Release Valve(TM)— 510(k) K212064

Name: FDA 510(k) clearance K212064
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Substantially Equivalent

Linear Health Sciences, LLC

FDA 510(k) clearance K212064 for Orchid Safety Release Valve(TM), Substantially Equivalent on 2022-05-03. Applicant: Linear Health Sciences, LLC. Device class: 2.

Clearance details

Applicant: Linear Health Sciences, LLC
Product code: Code QOI
Device class: Class 2
Regulation: 21 CFR 880.5220
Advisory panel: General Hospital
Date received: 2021-07-02
Decision date: 2022-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOI

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K241415 — Orchid Safety Release Valve2024-09-06
K232094 — Orchid Safety Release ValveTM2023-10-03
K231957 — SafeBreak® Vascular2023-09-29
K223486 — SafeBreak® Vascular2023-05-19
K230266 — Orchid Safety Release Valve2023-05-04

Adverse events under product code QOI

product code QOI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.