Cleared Traditional

K241415 - Orchid Safety Release Valve™ (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241415 · Linear Health Sciences, LLC · General Hospital
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Sep 2024
Decision
112d
Days
Class 2
Risk

K241415 is an FDA 510(k) clearance for the Orchid Safety Release Valve™. Classified as Intravenous Catheter Force-activated Separation Device. (product code QOI), Class II - Special Controls.

Submitted by Linear Health Sciences, LLC (Oklahoma City, US). The FDA issued a Cleared decision on September 6, 2024 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5220 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Linear Health Sciences, LLC devices

Submission Details

510(k) Number K241415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2024
Decision Date September 06, 2024
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QOI Intravenous Catheter Force-activated Separation Device.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5220
Definition An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QOI Intravenous Catheter Force-activated Separation Device.

All 7
Devices cleared under the same product code (QOI) and FDA review panel - the closest regulatory comparables to K241415.
Orchid Safety Release ValveTM
K232094 · Linear Health Sciences, LLC · Oct 2023
SafeBreak® Vascular
K231957 · Lineus Medical · Sep 2023
SafeBreak® Vascular
K223486 · Lineus Medical · May 2023
Orchid Safety Release Valve
K230266 · Linear Health Sciences, LLC · May 2023
SafeBreak Vascular
K222791 · Lineus Medical, LLC · Oct 2022
Orchid Safety Release Valve(TM)
K212064 · Linear Health Sciences, LLC · May 2022