510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153498Substantially Equivalent

Operio

Toul Meditech AB, Västerås, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153498 is the FDA 510(k) clearance record for Operio, a class II device, cleared for Toul Meditech AB on under FDA product code ORC (Air Filter Portable Apparatus). FDA's definition for product code ORC reads: "The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures". FDA records list 3 510(k) clearances for Toul Meditech AB, from to . As of , FDA records show no recalls naming K153498.

Clearance record

Decision date
Received
(226 days to decision)
Product code
ORC Air Filter Portable Apparatus
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Toul Meditech AB Tunbytorpsgatan 31, Västerås, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORC

Trailing 12 months

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

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