Cleared Traditional

K050434 - SHL DISPOSABLE AUTOINJECTOR

K050434 is an FDA 510(k) clearance for SHL DISPOSABLE AUTOINJECTOR, manufactured by Shl Medical, USA. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K050434 · Shl Medical, USA · General Hospital
Download Printable Device Report (PDF)
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Jun 2005
Decision
122d
Days
Class 2
Risk

K050434 is an FDA 510(k) clearance for the SHL DISPOSABLE AUTOINJECTOR. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Shl Medical, USA (Florham Park, US). The FDA issued a Cleared decision on June 24, 2005 after a review of 122 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.

View all Shl Medical, USA devices

FDA 510(k) Submission Details - K050434

510(k) Number K050434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date June 24, 2005
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
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 K050434.
AccuSert Needle Inserter
K213429 · Emed Technologies Corporation · Oct 2022
MiniMed Quick-serter
K160860 · Medtronic Minimed · Sep 2016
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · Elcam Medical Acal · Feb 2012
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