Cleared Traditional

K082587 - AUTO-SAFETY INJECTOR-2 (ASI-2)

K082587 is an FDA 510(k) clearance for AUTO-SAFETY INJECTOR-2 (ASI-2), manufactured by Medical House Products Limited. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K082587 · Medical House Products Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
24d
Days
Class 2
Risk

K082587 is an FDA 510(k) clearance for the AUTO-SAFETY INJECTOR-2 (ASI-2). Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Medical House Products Limited (Sheffield, GB). The FDA issued a Cleared decision on October 2, 2008 after a review of 24 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.

FDA 510(k) Submission Details - K082587

510(k) Number K082587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date October 02, 2008
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 40
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K082587.
LOBSTER AUTO-INJECTOR
K124026 · Scandinavian Health Limited · Sep 2013
AUTOJECT 2 FOR GLASSY SYRINGE
K122837 · Owen Mumford, Ltd. · Oct 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · Elcam Medical Acal · Feb 2012
COMPACT AUTO-SAFETY INJECTOR (CASI)
K073476 · Medical House (Asi) Limited · Mar 2008
DERMOTHERAP GUN
K062339 · Dermoequipos S.R.L. · Feb 2007
ACCU-CHEK LINKASSIST
K063146 · Disetronic Medical Systems AG · Nov 2006
K082587 · AUTO-SAFETY INJECTOR-2 (ASI-2)
Download PDF FDA Summary Medical House Product…