Cleared Traditional

K251849 - StaClear Syringe (SC250AN)

Also marketed or referenced as:
StaClear Syringe (SC250LS) StaClear Syringe (SC250LL)

K251849 is an FDA 510(k) clearance for StaClear Syringe (SC250AN), manufactured by Staclear, Inc.. The device is a Class 2 General Hospital device with product code QLY cleared through the Traditional 510(k) pathway after a 158-day FDA review.

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

FDA 510(k) Submission Details - K251849

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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 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
StaClear Syringe
K200242 · Tribofilm Research, Inc. · Jul 2020