510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853665Substantially Equivalent

Splash Adaptor

Ohio Medical Research, Inc., Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853665 is the FDA 510(k) clearance record for SPLASH ADAPTOR, a class I device, cleared for Ohio Medical Research, Inc. on under FDA product code BYH (Drain, Tee (Water Trap)). FDA records list one 510(k) clearance for Ohio Medical Research, Inc. As of , FDA records show no recalls naming K853665.

Clearance record

Decision date
Received
(37 days to decision)
Product code
BYH Drain, Tee (Water Trap)
Regulation
21 CFR 868.5995
Device class
Class I
Review panel
Anesthesiology
Applicant
Ohio Medical Research, Inc. 4353 Monroe St., Toledo OH
Third party review
No

Clearances, product code BYH

Trailing 12 months

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

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