Cleared Traditional

K160199 - Advocate Insulin Pen Needles

K160199 is an FDA 510(k) clearance for Advocate Insulin Pen Needles, manufactured by Diabetic Supply of Suncoast, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K160199 · Diabetic Supply of Suncoast, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
265d
Days
Class 2
Risk

K160199 is an FDA 510(k) clearance for the Advocate Insulin Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Diabetic Supply of Suncoast, Inc. (Dorado, US). The FDA issued a Cleared decision on October 19, 2016 after a review of 265 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 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.

FDA 510(k) Submission Details - K160199

510(k) Number K160199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2016
Decision Date October 19, 2016
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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

Matt Hedlund
Matt Hedlund

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 581
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K160199.
meso-relle (AAL34, AAL36, AM30G)
K161255 · Biotekne Srl · Jan 2017
BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Greiner Holdex
K160532 · Greiner Bio-One Na, Inc. · Nov 2016
CPL Insulin Pen Needle
K151090 · Cpl Co., Ltd. · Sep 2016
CareSens Pen Needle, Softip Pen Needle
K160575 · Yidobio, Inc. · Sep 2016
Insulin Pen Needle
K153706 · SteriLance Medical (Suzhou), Inc. · Aug 2016