Cleared Traditional

K073476 - COMPACT AUTO-SAFETY INJECTOR (CASI)

K073476 is an FDA 510(k) clearance for COMPACT AUTO-SAFETY INJECTOR (CASI), manufactured by Medical House (Asi) Limited. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K073476 · Medical House (Asi) Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
88d
Days
Class 2
Risk

K073476 is an FDA 510(k) clearance for the COMPACT AUTO-SAFETY INJECTOR (CASI). Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Medical House (Asi) Limited (Sheffield, GB). The FDA issued a Cleared decision on March 7, 2008 after a review of 88 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 Medical House (Asi) Limited devices

FDA 510(k) Submission Details - K073476

510(k) Number K073476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2007
Decision Date March 07, 2008
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 15
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K073476.
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