510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881282Substantially Equivalent

Xylene

Anatech, Ltd., Battle Creek MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881282 is the FDA 510(k) clearance record for XYLENE, a class I device, cleared for Anatech, Ltd. on under FDA product code KEM (Agent, Clearing). FDA records list 14 510(k) clearances for Anatech, Ltd., from to . As of , FDA records show no recalls naming K881282.

Clearance record

Decision date
Received
(11 days to decision)
Product code
KEM Agent, Clearing
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Anatech, Ltd. 1020 Harts Lake Rd., Battle Creek MI
Third party review
No

Clearances, product code KEM

Trailing 12 months

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

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