510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863635Substantially Equivalent

Updated Sterile Endotracheal Brushes

Biological & Environmental Control Laboratories, Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863635 is the FDA 510(k) clearance record for UPDATED STERILE ENDOTRACHEAL BRUSHES, a class I device, cleared for Biological & Environmental Control Laboratories on under FDA product code EPE (Brush, Cleaning, Tracheal Tube). FDA records list 20 510(k) clearances for Biological & Environmental Control Laboratories, from to . As of , FDA records show no recalls naming K863635.

Clearance record

Decision date
Received
(47 days to decision)
Product code
EPE Brush, Cleaning, Tracheal Tube
Regulation
21 CFR 868.5795
Device class
Class I
Review panel
Anesthesiology
Applicant
Biological & Environmental Control Laboratories 615 Front St., Toledo OH
Third party review
No

Clearances, product code EPE

Trailing 12 months

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

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