Cleared Special

Sol-M Luer Lock Syringe (K222744) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222744 · Sol-Millennium Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
29d
Days
Class 2
Risk

K222744 is an FDA 510(k) clearance for the Sol-M Luer Lock Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sol-Millennium Medical, Inc. (Suwanee, US). The FDA issued a Cleared decision on October 11, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sol-Millennium Medical, Inc. devices

Submission Details

510(k) Number K222744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2022
Decision Date October 11, 2022
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K222744.
Medwell Technology Ltd Syringes, various sizes
K212764 · Medwell Technology, Ltd. · Nov 2022
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K221308 · Jiangxi Maidikang Medical Devices Co., Ltd. · Oct 2022
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K221068 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Sterile Hypodermic Syringes for Single Use
K221079 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
K212846 · Jiangsu Jichun Medical Devices Co., Ltd. · Aug 2022