510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851034Substantially Equivalent

Novatherm

MedTech Products, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851034 is the FDA 510(k) clearance record for NOVATHERM, a class III device, cleared for Medtech Products, Inc. on under FDA product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)). FDA records list 14 510(k) clearances for Medtech Products, Inc., from to . As of , FDA records show no recalls naming K851034.

Clearance record

Decision date
Received
(198 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
Medtech Products, Inc. Mcdermott, Will & Emery, Washington DC
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