510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862478Substantially Equivalent

Hayes Vaginal Shield

Franklin Medical USA, Inc., Southfield MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862478 is the FDA 510(k) clearance record for HAYES VAGINAL SHIELD, a class I device, cleared for Franklin Medical USA, Inc. on under FDA product code HDF (Speculum, Vaginal, Metal). FDA records list 4 510(k) clearances for Franklin Medical USA, Inc., from to . As of , FDA records show no recalls naming K862478.

Clearance record

Decision date
Received
(147 days to decision)
Product code
HDF Speculum, Vaginal, Metal
Regulation
21 CFR 884.4520
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Franklin Medical USA, Inc. 26206 W. 12 Mile Rd., Southfield MI
Third party review
No

Clearances, product code HDF

Trailing 12 months

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

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