Cleared Abbreviated

K223376 - Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) (FDA 510(k) Clearance)

Also includes:
Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150) Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)

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

K223376 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
229d
Days
Class 2
Risk

K223376 is an FDA 510(k) clearance for the Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 21, 2023 after a review of 229 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cardinal Health200, LLC devices

Submission Details

510(k) Number K223376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2022
Decision Date June 21, 2023
Days to Decision 229 days
Submission Type Abbreviated
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
101d slower than avg
Panel avg: 128d · This submission: 229d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.