Cleared Traditional

K251849 - StaClear Syringe (SC250AN) (FDA 510(k) Clearance)

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

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

K251849 · Staclear, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
158d
Days
Class 2
Risk

K251849 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 November 21, 2025 after a review of 158 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 Staclear, Inc. devices

Submission Details

510(k) Number K251849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2025
Decision Date November 21, 2025
Days to Decision 158 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
30d slower than avg
Panel avg: 128d · This submission: 158d
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 K251849.
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
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