Cleared Traditional

Medifine Pen Needle 3 Bevel (K180720) - FDA 510(k) Clearance

Also marketed or referenced as:
Medifine Pen Needle Quinta 5 Bevel

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

K180720 · Medibio USA, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
100d
Days
Class 2
Risk

K180720 is an FDA 510(k) clearance for the Medifine Pen Needle 3 Bevel. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medibio USA, LLC (Cooper City, US). The FDA issued a Cleared decision on June 27, 2018 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Medibio USA, LLC devices

Submission Details

510(k) Number K180720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date June 27, 2018
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

LK Consulting Group USA, Inc.
Priscilla Chung

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 - FMI Needle, Hypodermic, Single Lumen

All 202
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K180720.
EasyTouch Safety Pen Needle
K163578 · Mhc Medical Products, LLC · Aug 2018
Autokeeper
K172095 · Medexel Co.,Ltd · Jul 2018
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
K173881 · Owen Mumford, Ltd. · Jul 2018
Kopac Sterile Needle
K172483 · Poonglim Pharmatech, Inc. · Jun 2018
Disposable Sterile Needle
K172938 · Jiangsu Caina Medical Co.,Ltd · Jun 2018
Omnican fine
K173803 · B.Braun Medical, Inc. · Jun 2018