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)
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.

View all Advanced Sterilization Products devices

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 46
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K030004.
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
K041984 · Best Sanitizers, Inc. · May 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · Healthpoint, Ltd. · May 2005
CIDEX OPA CONCENTRATE
K032959 · Advanced Sterilization Products · Apr 2005
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · Advanced Sterilization Products · Aug 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · Medivators, Inc. · Aug 2000
CIDEX OPA SOLUTION
K001381 · Advanced Sterilization Products · May 2000