Cleared Traditional

K252279 - Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (FDA 510(k) Clearance)

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

K252279 · Chirana T.Injecta,A.S. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
269d
Days
Class 2
Risk

K252279 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Chirana T.Injecta,A.S. (Stará Turá, SK). The FDA issued a Cleared decision on April 17, 2026 after a review of 269 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 Chirana T.Injecta,A.S. devices

Submission Details

510(k) Number K252279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2025
Decision Date April 17, 2026
Days to Decision 269 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
141d slower than avg
Panel avg: 128d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 748
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K252279.
Profoject™ Insulin Syringes
K253068 · CMT Health PTE., Ltd. · Feb 2026
Instylla Delivery Kit
K253769 · Instylla, Inc. · Dec 2025
DuoprossTM Smart Cap (Type I)
K252518 · Duopross Meditech Corporate · Dec 2025
EXEL Disposable Syringe
K251089 · Exelint International, Co. · Dec 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2025
Merit Syringe
K250853 · Merit Medical Systems, Inc. · Nov 2025