Cleared Traditional

K243149 - Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (FDA 510(k) Clearance)

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

K243149 · Congruence Medical Solutions, LLC · General Hospital
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Dec 2024
Decision
81d
Days
Class 2
Risk

K243149 is an FDA 510(k) clearance for the Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models). Classified as Ophthalmic Syringe (product code QLY), Class II - Special Controls.

Submitted by Congruence Medical Solutions, LLC (Baltimore, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Congruence Medical Solutions, LLC devices

Submission Details

510(k) Number K243149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date December 20, 2024
Days to Decision 81 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
47d faster than avg
Panel avg: 128d · This submission: 81d
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 Peers - QLY Ophthalmic Syringe

Devices cleared under the same product code (QLY) and FDA review panel - the closest regulatory comparables to K243149.
StaClear Syringe (SC250AN)
K251849 · Staclear, Inc. · Nov 2025
Altaviz Intravitreal Syringe
K243322 · Altaviz, LLC · May 2025
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
K243027 · Hangzhou Sightnovo Medical Technology Co., Ltd. · Apr 2025
StaClear Syringe (SC250AN)
K243936 · Staclear, Inc. · Apr 2025
VitreJect Syringe
K230372 · Ocuject, LLC · Sep 2023