510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K932133Substantially Equivalent

Eysotek

Isotech Corp., Wethersfield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932133 is the FDA 510(k) clearance record for EYSOTEK, a class II device, cleared for Isotech Corp. on under FDA product code FXX (Mask, Surgical). FDA records list 2 510(k) clearances for Isotech Corp. As of , FDA records show no recalls naming K932133.

Clearance record

Decision date
Received
(361 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Isotech Corp. 376 Wels Rd., Wethersfield CT
510(k) summary
Summary
Third party review
No

Clearances, product code FXX

Trailing 12 months
8 clearances under product code FXX in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
November 20251
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260