510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802285Substantially Equivalent

Ohio Thoracic Suction Regulator

Ohio Medical Products, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802285 is the FDA 510(k) clearance record for OHIO THORACIC SUCTION REGULATOR, a class I device, cleared for Ohio Medical Products on under FDA product code KOP (Adhesive, Denture, Karaya). FDA records list 47 510(k) clearances for Ohio Medical Products, from to . As of , FDA records show no recalls naming K802285.

Clearance record

Decision date
Received
(14 days to decision)
Product code
KOP Adhesive, Denture, Karaya
Regulation
21 CFR 872.3450
Device class
Class I
Review panel
Dental
Applicant
Ohio Medical Products 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KOP

Trailing 12 months

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

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