Cleared Traditional

K993385 - AUTOJET 2 (NON-FIXED NEEDLE TYPE)

K993385 is an FDA 510(k) clearance for AUTOJET 2 (NON-FIXED NEEDLE TYPE), 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 33-day FDA review.

K993385 · Owen Mumford USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
33d
Days
Class 2
Risk

K993385 is an FDA 510(k) clearance for the AUTOJET 2 (NON-FIXED NEEDLE TYPE). 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 November 10, 1999 after a review of 33 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Owen Mumford USA, Inc. devices

FDA 510(k) Submission Details - K993385

510(k) Number K993385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date November 10, 1999
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 29
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K993385.
EZ-JECT
K051667 · Indolor, Ltd. · Sep 2005
SHL DISPOSABLE AUTOINJECTOR
K050434 · Shl Medical, USA · Jun 2005
INNOJECT AUTO-INJECTOR
K042557 · Innoject, Inc. · Nov 2004
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
SOFTINJECT
K991680 · Androsystems Srl · Jun 1999
AUTO-INJECTOR, SURE-INJECT 2000
K981266 · Mighty Mo, Corp. · Jul 1998