510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902032Substantially Equivalent

O. B. Pack IV

Customed, Inc, Fajardo PR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902032 is the FDA 510(k) clearance record for O. B. PACK IV, a class II device, cleared for Customed, Inc. on under FDA product code HFC (Aspirator, Endocervical). FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show 2 recalls naming K902032.

Clearance record

Decision date
Received
(147 days to decision)
Product code
HFC Aspirator, Endocervical
Regulation
21 CFR 884.1050
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Customed, Inc. Calle Igualdad #7, Fajardo PR
Third party review
No

Clearances, product code HFC

Trailing 12 months

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

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