Cleared Traditional

K060389 - CONFIDOSE IM AUTO-INJECTOR

K060389 is an FDA 510(k) clearance for CONFIDOSE IM AUTO-INJECTOR, manufactured by Pharma-Pen, Inc.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K060389 · Pharma-Pen, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
112d
Days
Class 2
Risk

K060389 is an FDA 510(k) clearance for the CONFIDOSE IM AUTO-INJECTOR. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Pharma-Pen, Inc. (Washington, US). The FDA issued a Cleared decision on June 6, 2006 after a review of 112 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K060389

510(k) Number K060389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date June 06, 2006
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 45
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K060389.
DERMOTHERAP GUN
K062339 · Dermoequipos S.R.L. · Feb 2007
ACCU-CHEK LINKASSIST
K063146 · Disetronic Medical Systems AG · Nov 2006
DAI-R
K060141 · Shl Medical, USA · Jun 2006
EZ-JECT
K051667 · Indolor, Ltd. · Sep 2005
SHL DISPOSABLE AUTOINJECTOR
K050434 · Shl Medical, USA · Jun 2005
PERSONAL INJECTOR
K033696 · Union Medico Aps · Feb 2005
K060389 · CONFIDOSE IM AUTO-INJECTOR
Download PDF FDA Summary Pharma-Pen, Inc.