510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902271Substantially Equivalent

O. B. Pack I

Customed, Inc, Carolina Puerto Rico / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902271 is the FDA 510(k) clearance record for O. B. PACK I, a class I device, cleared for Customed, Inc. on under FDA product code HHD (Pad, Menstrual, Unscented). FDA's definition for product code HHD reads: "An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile". FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show 5 recalls naming K902271.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HHD Pad, Menstrual, Unscented
Regulation
21 CFR 884.5435
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Customed, Inc. Call Box 158, Carolina Puerto Rico
Third party review
No

Clearances, product code HHD

Trailing 12 months

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

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