Cleared Traditional

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

K243149 is an FDA 510(k) clearance for Microliter Dosing Syringe (9, manufactured by Congruence Medical Solutions, LLC. The device is a Class 2 General Hospital device with product code QLY cleared through the Traditional 510(k) pathway after a 81-day FDA review.

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

FDA 510(k) Submission Details - K243149

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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QLY Device Classification - Class 2, Special Controls

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.
Altaviz Intravitreal Syringe
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StaClear Syringe (SC250AN)
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K200242 · Tribofilm Research, Inc. · Jul 2020