Cleared Traditional

StaClear Syringe (K200242) - FDA 510(k) Clearance

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

K200242 · Tribofilm Research, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
178d
Days
Class 2
Risk

K200242 is an FDA 510(k) clearance for the StaClear Syringe. Classified as Ophthalmic Syringe (product code QLY), Class II - Special Controls.

Submitted by Tribofilm Research, Inc. (Raleigh, US). The FDA issued a Cleared decision on July 27, 2020 after a review of 178 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Tribofilm Research, Inc. devices

Submission Details

510(k) Number K200242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2020
Decision Date July 27, 2020
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLY Ophthalmic Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition An Ophthalmic Syringe Is A Piston Syringe Intended For Intraocular Injections. The Device Consists Of A Calibrated Hollow Barrel, A Movable Plunger, And May Include A Needle. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye.
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

Namsa
Beryl St. Jeanne

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 - QLY Ophthalmic Syringe

Devices cleared under the same product code (QLY) and FDA review panel - the closest regulatory comparables to K200242.
StaClear Syringe (SC250AN)
K251849 · Staclear, Inc. · Nov 2025
Altaviz Intravitreal Syringe
K243322 · Altaviz, LLC · May 2025
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K243027 · Hangzhou Sightnovo Medical Technology Co., Ltd. · Apr 2025
StaClear Syringe (SC250AN)
K243936 · Staclear, Inc. · Apr 2025
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
K243149 · Congruence Medical Solutions, LLC · Dec 2024
VitreJect Syringe
K230372 · Ocuject, LLC · Sep 2023