Cleared Traditional

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539) - FDA 510(k) Clearance

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

K190539 · Monumedical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
232d
Days
Class 2
Risk

K190539 is an FDA 510(k) clearance for the TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSign.... Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Monumedical, LLC (Roseville, US). The FDA issued a Cleared decision on October 22, 2019 after a review of 232 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 Monumedical, LLC devices

Submission Details

510(k) Number K190539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date October 22, 2019
Days to Decision 232 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
103d slower than avg
Panel avg: 129d · This submission: 232d
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 Consultant

Cheryl Blake
Cheryl Blake

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMG Stopcock, I.v. Set

All 88
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K190539.
Qitexio® 4-Way Stopcock (QIT014)
K242255 · Medex · Apr 2025
Three Way Stop Cock
K223499 · M/S Romsons International · Jul 2023
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
Elcam Stopcocks and Manifolds
K190489 · Elcam Medical Acal · Apr 2019