510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102499Substantially Equivalent

Duofertility

Cambridge Temperature Concepts, Ltd., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102499 is the FDA 510(k) clearance record for DUOFERTILITY, cleared for Cambridge Temperature Concepts , Ltd. on under FDA product code LHD (Device, Fertility Diagnostic, Proceptive). FDA records list one 510(k) clearance for Cambridge Temperature Concepts , Ltd. As of , FDA records show no recalls naming K102499.

Clearance record

Decision date
Received
(476 days to decision)
Product code
LHD Device, Fertility Diagnostic, Proceptive
Device class
Unclassified
Review panel
Unknown
Applicant
Cambridge Temperature Concepts , Ltd. P.O. Box 390930, Cambridge MA
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