Orchid Safety Release Valve— 510(k) K230266

Name: FDA 510(k) clearance K230266
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Substantially Equivalent

Linear Health Sciences, LLC

FDA 510(k) clearance K230266 for Orchid Safety Release Valve, Substantially Equivalent on 2023-05-04. 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: 2023-01-31
Decision date: 2023-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOI

view all

K241415 — Orchid Safety Release Valve2024-09-06
K232094 — Orchid Safety Release ValveTM2023-10-03
K231957 — SafeBreak® Vascular2023-09-29
K223486 — SafeBreak® Vascular2023-05-19
K222791 — SafeBreak Vascular2022-10-16

More clearances from Linear Health Sciences, LLC

view all

K212064 — Orchid Safety Release Valve(TM)2022-05-03

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.