Cleared Traditional

K030004 - 0.55% ORTH-PHTHALALDEHYDE SOLUTION

K030004 is an FDA 510(k) clearance for 0.55% ORTH-PHTHALALDEHYDE SOLUTION, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K030004 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
56d
Days
Class 2
Risk

K030004 is an FDA 510(k) clearance for the 0.55% ORTH-PHTHALALDEHYDE SOLUTION. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on February 27, 2003 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 - K030004

510(k) Number K030004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date February 27, 2003
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 64
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K030004.
CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
K033381 · Discus Dental, Inc. · Jan 2004
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
K012889 · Pascal Co., Inc. · May 2003
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
K013280 · Sterilox Technologies, Inc. · Sep 2002
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K003087 · Sporicidin Intl. · Nov 2000
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000
K030004 · 0.55% ORTH-PHTHALALDEHYDE SOLUTION
Download PDF FDA Summary Advanced Sterilizatio…