Cleared Traditional

K160860 - MiniMed Quick-serter

K160860 is an FDA 510(k) clearance for MiniMed Quick-serter, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K160860 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
177d
Days
Class 2
Risk

K160860 is an FDA 510(k) clearance for the MiniMed Quick-serter. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 177 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 Medtronic Minimed devices

FDA 510(k) Submission Details - K160860

510(k) Number K160860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2016
Decision Date September 22, 2016
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 Peers - KZH Introducer, Syringe Needle

All 23
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K160860.
GripMate
K243232 · Synthon Hispania S.L. · Dec 2024
AccuSert Needle Inserter
K213429 · Emed Technologies Corporation · Oct 2022
Orbit Inserter
K163400 · Ypsomed AG · Jul 2017
WHISPERJECT AUTOINJECTOR
K141384 · Scandinavian Health Limited · Sep 2014
LOBSTER AUTO-INJECTOR
K124026 · Scandinavian Health Limited · Sep 2013
AUTOJECT 2 FOR GLASSY SYRINGE
K122837 · Owen Mumford, Ltd. · Oct 2012