510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943752Substantially Equivalent

Rimeco Midstream Urine Collector

Rimeco Products, Inc., Oakwood Village OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943752 is the FDA 510(k) clearance record for RIMECO MIDSTREAM URINE COLLECTOR, a class II device, cleared for Rimeco Products, Inc. on under FDA product code FOC (Bag, Urine Collection, Newborn). FDA records list one 510(k) clearance for Rimeco Products, Inc. As of , FDA records show no recalls naming K943752.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FOC Bag, Urine Collection, Newborn
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rimeco Products, Inc. 7603 - B9 First Pl. Dr., Oakwood Village OH
510(k) summary
Statement
Third party review
No

Clearances, product code FOC

Trailing 12 months

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

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