510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031660Substantially Equivalent

Ferris Polymem Sterile Breast Pad

Ferris Mfg. Corp., Burr Ridge IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031660 is the FDA 510(k) clearance record for FERRIS POLYMEM STERILE BREAST PAD, a class I device, cleared for Ferris Mfg. Corp. on under FDA product code NTX (Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)). FDA's definition for product code NTX reads: "A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING". FDA records list 20 510(k) clearances for Ferris Mfg. Corp., from to . As of , FDA records show no recalls naming K031660.

Clearance record

Decision date
Received
(636 days to decision)
Product code
NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Applicant
Ferris Mfg. Corp. 16 W. 300 83rd St., Burr Ridge IL
510(k) summary
Statement
Third party review
No

Clearances, product code NTX

Trailing 12 months

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

FDA records show no clearances under product code NTX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTX, 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