Cleared Traditional

K030004 - 0.55% ORTH-PHTHALALDEHYDE SOLUTION

K030004 is the FDA 510(k) clearance for 0.55% ORTH-PHTHALALDEHYDE SOLUTION by Advanced Sterilization Products. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 26
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K030004.
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K002401 · Advanced Sterilization Products · Aug 2000
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