Cleared Special

K243936 - StaClear Syringe (SC250AN) (FDA 510(k) Clearance)

Also includes:
StaClear Syringe (SC250LS) StaClear Syringe (SC250LL)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243936 · Staclear, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
104d
Days
Class 2
Risk

K243936 is an FDA 510(k) clearance for the StaClear Syringe (SC250AN). Classified as Ophthalmic Syringe (product code QLY), Class II - Special Controls.

Submitted by Staclear, Inc. (Raleigh, US). The FDA issued a Cleared decision on April 3, 2025 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Staclear, Inc. devices

Submission Details

510(k) Number K243936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date April 03, 2025
Days to Decision 104 days
Submission Type Special
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
24d faster than avg
Panel avg: 128d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 K243936.
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
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