Cleared Traditional

K033696 - PERSONAL INJECTOR

K033696 is an FDA 510(k) clearance for PERSONAL INJECTOR, manufactured by Union Medico Aps. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K033696 · Union Medico Aps · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
449d
Days
Class 2
Risk

K033696 is an FDA 510(k) clearance for the PERSONAL INJECTOR. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Union Medico Aps (Copenhagen, DK). The FDA issued a Cleared decision on February 16, 2005 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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: 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.

FDA 510(k) Submission Details - K033696

510(k) Number K033696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date February 16, 2005
Days to Decision 449 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
320d slower than avg
Panel avg: 129d · This submission: 449d
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 K033696.
CONFIDOSE IM AUTO-INJECTOR
K060389 · Pharma-Pen, Inc. · Jun 2006
EZ-JECT
K051667 · Indolor, Ltd. · Sep 2005
SHL DISPOSABLE AUTOINJECTOR
K050434 · Shl Medical, USA · Jun 2005
INNOJECT AUTO-INJECTOR
K042557 · Innoject, Inc. · Nov 2004
MEDSAFE SYSTEM INSERTER
K032848 · Medsolve Technologies, LLC · Apr 2004
INVISIJECT RESUSABLE AUTO-INJECTOR
K032425 · Biogen · Nov 2003
K033696 · PERSONAL INJECTOR
Download PDF FDA Summary Union Medico Aps