510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812701Substantially Equivalent

Ortho-Therm Infrared Sensor

Orthion Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812701 is the FDA 510(k) clearance record for ORTHO-THERM INFRARED SENSOR, a class III device, cleared for Orthion Corp. on under FDA product code IYM (System, Telethermographic, Infrared). FDA records list 11 510(k) clearances for Orthion Corp., from to . As of , FDA records show no recalls naming K812701.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IYM System, Telethermographic, Infrared
Regulation
21 CFR 884.2980
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
Orthion Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IYM

Trailing 12 months

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

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