Cleared Traditional

Luer Lock Syringe with Safety Needle (K241821) - FDA 510(k) Clearance

Also marketed or referenced as:
Luer Lock Syringe with Exchangeable Needle Luer Lock Syringe with Blunt Fill Needle

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

K241821 · Sol-Millennium Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
88d
Days
Class 2
Risk

K241821 is an FDA 510(k) clearance for the Luer Lock Syringe with 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 September 20, 2024 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sol-Millennium Medical, Inc. devices

Submission Details

510(k) Number K241821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2024
Decision Date September 20, 2024
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 Consultant

Shanghai Mind-Link Consulting Co., Ltd.
Alice Huang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 240
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