510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852194Substantially Equivalent

Model Mt-50 Digital Memory Fever & Basal Thermomet

Sharp Electronics Corp., Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852194 is the FDA 510(k) clearance record for MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET, cleared for Sharp Electronics Corp. on under FDA product code LHD (Device, Fertility Diagnostic, Proceptive). FDA records list 10 510(k) clearances for Sharp Electronics Corp., from to . As of , FDA records show no recalls naming K852194.

Clearance record

Decision date
Received
(130 days to decision)
Product code
LHD Device, Fertility Diagnostic, Proceptive
Device class
Unclassified
Review panel
Unknown
Applicant
Sharp Electronics Corp. 10 Sharp Plz., Paramus NJ
Third party review
No

Clearances, product code LHD

Trailing 12 months

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

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