Cleared Traditional

K000482 - MODIFICATION TO AUTOJECT MINI

K000482 is an FDA 510(k) clearance for MODIFICATION TO AUTOJECT MINI, manufactured by Owen Mumford, Ltd.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K000482 · Owen Mumford, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
21d
Days
Class 2
Risk

K000482 is an FDA 510(k) clearance for the MODIFICATION TO AUTOJECT MINI. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Owen Mumford, Ltd. (Marietta, US). The FDA issued a Cleared decision on March 6, 2000 after a review of 21 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, Ltd. devices

FDA 510(k) Submission Details - K000482

510(k) Number K000482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2000
Decision Date March 06, 2000
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 K000482.
GripMate
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MiniMed Quick-serter
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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