510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021978Substantially Equivalent

Petit Sophia

Nishitomo Co., Inc., Gray LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021978 is the FDA 510(k) clearance record for PETIT SOPHIA, cleared for Nishitomo Co., Inc. on under FDA product code LHD (Device, Fertility Diagnostic, Proceptive). FDA records list 2 510(k) clearances for Nishitomo Co., Inc., from to . As of , FDA records show no recalls naming K021978.

Clearance record

Decision date
Received
(295 days to decision)
Product code
LHD Device, Fertility Diagnostic, Proceptive
Device class
Unclassified
Review panel
Unknown
Applicant
Nishitomo Co., Inc. 3696 W. Main St., Gray LA
510(k) summary
Summary PDF
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