Cleared Traditional

K251089 - EXEL Disposable Syringe

Also marketed or referenced as:
EXEL Disposable Syringe with Needle EXEL Disposable Syringe with Secure Touch® Safety Needle EXEL Disposable Hypodermic Needle

K251089 is an FDA 510(k) clearance for EXEL Disposable Syringe, manufactured by Exelint International, Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K251089 · Exelint International, Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
246d
Days
Class 2
Risk

K251089 is an FDA 510(k) clearance for the EXEL Disposable Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Exelint International, Co. (Redondo Beach, US). The FDA issued a Cleared decision on December 12, 2025 after a review of 246 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 Exelint International, Co. devices

FDA 510(k) Submission Details - K251089

510(k) Number K251089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2025
Decision Date December 12, 2025
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K251089.
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K250510 · Shina Med Corporation · Oct 2025