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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 45
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K050434.
DAI-R
K060141 · Shl Medical, USA · Jun 2006
CONFIDOSE IM AUTO-INJECTOR
K060389 · Pharma-Pen, Inc. · Jun 2006
EZ-JECT
K051667 · Indolor, Ltd. · Sep 2005
PERSONAL INJECTOR
K033696 · Union Medico Aps · Feb 2005
INNOJECT AUTO-INJECTOR
K042557 · Innoject, Inc. · Nov 2004
MEDSAFE SYSTEM INSERTER
K032848 · Medsolve Technologies, LLC · Apr 2004
K050434 · SHL DISPOSABLE AUTOINJECTOR
Download PDF FDA Summary Shl Medical, USA