510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854512Substantially Equivalent

Tubing Clamp Cat#1000-a

Rao Medical Devices, Inc., Hudson OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854512 is the FDA 510(k) clearance record for TUBING CLAMP CAT#1000-A, a class I device, cleared for Rao Medical Devices, Inc. on under FDA product code FKK (Clamp, Line). FDA records list 2 510(k) clearances for Rao Medical Devices, Inc., from to . As of , FDA records show no recalls naming K854512.

Clearance record

Decision date
Received
(20 days to decision)
Product code
FKK Clamp, Line
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Rao Medical Devices, Inc. P.O. Box 621, 1550 Winchell, Hudson OH
Third party review
No

Clearances, product code FKK

Trailing 12 months

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

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