510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961442Substantially Equivalent

Universal Drainage Tray

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

K961442 is the FDA 510(k) clearance record for UNIVERSAL DRAINAGE TRAY, a class II device, cleared for Customed, Inc. on under FDA product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)). FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show 2 recalls naming K961442.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Customed, Inc. Calle Igualdad #7, Fajardo PR
510(k) summary
Statement
Third party review
No

Clearances, product code FCM

Trailing 12 months
1 clearance under product code FCM in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FCM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260