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
K971303Substantially Equivalent

Instead, Softcup

Ultrafem, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971303 is the FDA 510(k) clearance record for INSTEAD, SOFTCUP, a class II device, cleared for Ultrafem, Inc. on under FDA product code HHE (Cup, Menstrual). FDA's definition for product code HHE reads: "A menstrual cup is a receptacle placed in the vagina to collect menstrual flow". FDA records list 2 510(k) clearances for Ultrafem, Inc., from to . As of , FDA records show no recalls naming K971303.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HHE Cup, Menstrual
Regulation
21 CFR 884.5400
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ultrafem, Inc. 1050 Connecticut Ave., NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code HHE

Trailing 12 months

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

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