Cleared Traditional

EasyTouch Safety Pen Needle (K163578) - FDA 510(k) Clearance

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

K163578 · Mhc Medical Products, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
591d
Days
Class 2
Risk

K163578 is an FDA 510(k) clearance for the EasyTouch Safety Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Mhc Medical Products, LLC (Fairfield, US). The FDA issued a Cleared decision on August 3, 2018 after a review of 591 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Mhc Medical Products, LLC devices

Submission Details

510(k) Number K163578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date August 03, 2018
Days to Decision 591 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
462d slower than avg
Panel avg: 129d · This submission: 591d
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

Kamm & Associates
Daniel Kamm

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 K163578.
EZ-IO Intraosseous Vascular Access System
K180395 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Nov 2018
Disposable Insulin Pen Needle
K181069 · Zhejiang Kindly Medical Devices Co., Ltd. · Aug 2018
BD Vacutainer Eclipse Signal Blood Collection Needle
K170824 · Becton, Dickinson and Company · 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
Medifine Pen Needle 3 Bevel
K180720 · Medibio USA, LLC · Jun 2018