510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781916Substantially Equivalent

Flext-Therm

E-Z-EM, Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781916 is the FDA 510(k) clearance record for FLEXT-THERM, a class III device, cleared for E-Z-Em, Inc. on under FDA product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K781916.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Regulation
21 CFR 884.2982
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
E-Z-Em, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KXZ

Trailing 12 months

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

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