Cleared Traditional

K945660 - AUTOJECT 2

K945660 is an FDA 510(k) clearance for AUTOJECT 2, manufactured by Owen Mumford USA, Inc.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K945660 · Owen Mumford USA, Inc. · General Hospital
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Aug 1995
Decision
267d
Days
Class 2
Risk

K945660 is an FDA 510(k) clearance for the AUTOJECT 2. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Owen Mumford USA, Inc. (Marietta, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 267 days - an extended review cycle.

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 Owen Mumford USA, Inc. devices

FDA 510(k) Submission Details - K945660

510(k) Number K945660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date August 11, 1995
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
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 9
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K945660.
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · Medtronic Minimed · Mar 1997
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · Hdc Corp. · Jun 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473 · Hdc Corp. · Jan 1995
MONOJECT INJECTOMATIC
K832683 · Sherwood Medical Co. · Sep 1983