Cleared Traditional

K231907 - Medline Safety Insulin and TB Syringes

K231907 is an FDA 510(k) clearance for Medline Safety Insulin and TB Syringes, manufactured by Medline Industries, LP. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K231907 · Medline Industries, LP · General Hospital
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Oct 2023
Decision
111d
Days
Class 2
Risk

K231907 is an FDA 510(k) clearance for the Medline Safety Insulin and TB Syringes. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on October 18, 2023 after a review of 111 days - within the typical 510(k) review window.

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 Medline Industries, LP devices

FDA 510(k) Submission Details - K231907

510(k) Number K231907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2023
Decision Date October 18, 2023
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 95
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K231907.
VaporShield
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SaviSafe Safety Device
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Shina Syringe
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Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
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K221981 · Roncadelle Operations Srl · Dec 2022