510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K934666Substantially Equivalent

Pds Ultraclean

Medical Polymers, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934666 is the FDA 510(k) clearance record for PDS ULTRACLEAN, a class I device, cleared for Medical Polymers, Inc. on under FDA product code FLG (Cleaner, Ultrasonic, Medical Instrument). FDA records list 3 510(k) clearances for Medical Polymers, Inc., from to . As of , FDA records show no recalls naming K934666.

Clearance record

Decision date
Received
(199 days to decision)
Product code
FLG Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Applicant
Medical Polymers, Inc. 8920 Business Park Dr., Austin TX
510(k) summary
Statement
Third party review
No

Clearances, product code FLG

Trailing 12 months

FDA records hold no clearances under product code FLG in the trailing twelve months.

FDA records show no clearances under product code FLG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FLG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260