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)
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.

View all Union Medico Aps devices

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
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 17
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K033696.
AccuSert Needle Inserter
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FLEXI-Q DV AND DVR AUTO-INJECTORS
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AUTOJET 2 (NON-FIXED NEEDLE TYPE)
K993385 · Owen Mumford USA, Inc. · Nov 1999
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
SOFTINJECT
K991680 · Androsystems Srl · Jun 1999