510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242031Substantially Equivalent

Béa Applicator (BAP-GB-01)

Stepone Fertility Ltd (T/A Béa Fertility), London, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242031 is the FDA 510(k) clearance record for Béa Applicator (BAP-GB-01), a class II device, cleared for Stepone Fertility Ltd (T/A Béa Fertility) on under FDA product code HDR (Cap, Cervical). FDA records list one 510(k) clearance for Stepone Fertility Ltd (T/A Béa Fertility). As of , FDA records show no recalls naming K242031.

Clearance record

Decision date
Received
(265 days to decision)
Product code
HDR Cap, Cervical
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Stepone Fertility Ltd (T/A Béa Fertility) 71-75 Shelton St., London, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDR

Trailing 12 months

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

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