510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991263Substantially Equivalent

Thermoplate

Tokai Hit Co., Ltd., Fujinomiya-Shi, Shizuoka-Ken, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991263 is the FDA 510(k) clearance record for THERMOPLATE, a class II device, cleared for Tokai Hit Co., Ltd. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list one 510(k) clearance for Tokai Hit Co., Ltd. As of , FDA records show no recalls naming K991263.

Clearance record

Decision date
Received
(86 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Tokai Hit Co., Ltd. 306-1 Gendoji-Cho, Fujinomiya-Shi, Shizuoka-Ken, JP
510(k) summary
Summary
Third party review
No

Clearances, product code MQG

Trailing 12 months
2 clearances under product code MQG in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260