Cleared Traditional

Three Way Stop Cock (K223499) - FDA 510(k) Clearance

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

K223499 · M/S Romsons International · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
242d
Days
Class 2
Risk

K223499 is an FDA 510(k) clearance for the Three Way Stop Cock. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by M/S Romsons International (Noida, IN). The FDA issued a Cleared decision on July 21, 2023 after a review of 242 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 M/S Romsons International devices

Submission Details

510(k) Number K223499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2022
Decision Date July 21, 2023
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FMG Stopcock, I.v. Set

All 20
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K223499.
Qitexio® 4-Way Stopcock (QIT014)
K242255 · Medex · Apr 2025
lntravascular Administration Sets with Stopcock and Manifold
K223175 · Baxter Healthcare Corporation · Mar 2023
SafePort(TM) Manifold (or Stopcock)
K211204 · Elcam Medical Acal · Sep 2022
Clicky Cross
K210516 · Yomura Technologies, Inc. · May 2022
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
K190539 · Monumedical, LLC · Oct 2019
Elcam Stopcocks and Manifolds
K190489 · Elcam Medical Acal · Apr 2019