Cleared Traditional

K163400 - Orbit Inserter

K163400 is an FDA 510(k) clearance for Orbit Inserter, manufactured by Ypsomed AG. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K163400 · Ypsomed AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
233d
Days
Class 2
Risk

K163400 is an FDA 510(k) clearance for the Orbit Inserter. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on July 26, 2017 after a review of 233 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 Ypsomed AG devices

FDA 510(k) Submission Details - K163400

510(k) Number K163400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date July 26, 2017
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
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 9
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K163400.
GripMate
K243232 · Synthon Hispania S.L. · Dec 2024
AccuSert Needle Inserter
K213429 · Emed Technologies Corporation · Oct 2022
MiniMed Quick-serter
K160860 · Medtronic Minimed · Sep 2016
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · Medtronic Minimed · Mar 1997