510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852950Substantially Equivalent

Visitherm

C.D. Regelin & Associates, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852950 is the FDA 510(k) clearance record for VISITHERM, a class III device, cleared for C.D. Regelin & Associates, Inc. on under FDA product code IYM (System, Telethermographic, Infrared). FDA records list one 510(k) clearance for C.D. Regelin & Associates, Inc. As of , FDA records show no recalls naming K852950.

Clearance record

Decision date
Received
(211 days to decision)
Product code
IYM System, Telethermographic, Infrared
Regulation
21 CFR 884.2980
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
C.D. Regelin & Associates, Inc. 4156 Library Rd., Pittsburgh PA
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