510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052858Substantially Equivalent

Soothies Gel Pads

Puronxy, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052858 is the FDA 510(k) clearance record for SOOTHIES GEL PADS, a class I device, cleared for Puronxy, Inc. on under FDA product code NXH (Nursing Pad, Cohesive Gel). FDA's definition for product code NXH reads: "Intended to relieve nipples that are sore and cracked from breast feeding". FDA records list one 510(k) clearance for Puronxy, Inc. As of , FDA records show no recalls naming K052858.

Clearance record

Decision date
Received
(121 days to decision)
Product code
NXH Nursing Pad, Cohesive Gel
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Applicant
Puronxy, Inc. 9853 Pacific Heights Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXH

Trailing 12 months

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

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