Cleared Traditional

Sol-Glide Safety Needle (K253110) - FDA 510(k) Clearance

Also marketed or referenced as:
Sol-Glide Safety Needle with Syringe

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

K253110 · Sol-Millennium Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
267d
Days
Class 2
Risk

K253110 is an FDA 510(k) clearance for the Sol-Glide Safety Needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sol-Millennium Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on June 18, 2026 after a review of 267 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 Sol-Millennium Medical, Inc. devices

Submission Details

510(k) Number K253110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2025
Decision Date June 18, 2026
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K253110.
Sofjec (Single use Needle)
K253112 · Hlb Lifescience Co., Ltd. · May 2026
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
K252279 · Chirana T.Injecta,A.S. · Apr 2026
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