510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K030004Substantially Equivalent

0.55% Orth-Phthalaldehyde Solution

Advanced Sterilization Products, Irvin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030004 is the FDA 510(k) clearance record for 0.55% ORTH-PHTHALALDEHYDE SOLUTION, a class II device, cleared for Advanced Sterilization Products on under FDA product code MED (Sterilant, Medical Devices). FDA records list 59 510(k) clearances for Advanced Sterilization Products, from to . As of , FDA records show 2 recalls naming K030004.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
Advanced Sterilization Products 33 Technology Dr., Irvin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260