Cleared Abbreviated

K230070 - MESORAM® Hypodermic Needle (710301) (FDA 510(k) Clearance)

Also includes:
MESORAM® Hypodermic Needle (710302) MESORAM® Hypodermic Needle (712305) MESORAM® Hypodermic Needle (712315) MESORAM® Hypodermic Needle (710303) MESORAM® Hypodermic Needle (710307) MESORAM® Hypodermic Needle (710306) MESORAM® Hypodermic Needle (712308) MESORAM® Hypodermic Needle (712318) MESORAM® Hypodermic Needle (712303) MESORAM® Hypodermic Needle (712307) MESORAM® Hypodermic Needle (712306) MESORAM® Hypodermic Needle (812400) MESORAM®

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

K230070 · Promamedical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
268d
Days
Class 2
Risk

K230070 is an FDA 510(k) clearance for the MESORAM® Hypodermic Needle (710301). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Promamedical, Inc. (Miami, US). The FDA issued a Cleared decision on October 5, 2023 after a review of 268 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Promamedical, Inc. devices

Submission Details

510(k) Number K230070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2023
Decision Date October 05, 2023
Days to Decision 268 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
140d slower than avg
Panel avg: 128d · This submission: 268d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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

Nilo Medical Consulting Group, LLC
Michael Nilo

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.

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All 688
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