510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112200Substantially Equivalent

Focus Touch Conception System

Intimate Bridge 2 Conception, Inc., Murrysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112200 is the FDA 510(k) clearance record for FOCUS TOUCH CONCEPTION SYSTEM, a class II device, cleared for Intimate Bridge 2 Conception, Inc. on under FDA product code OBB (Kit, Conception-Assist, Home Use). FDA's definition for product code OBB reads: "The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap...". FDA records list one 510(k) clearance for Intimate Bridge 2 Conception, Inc. As of , FDA records show no recalls naming K112200.

Clearance record

Decision date
Received
(402 days to decision)
Product code
OBB Kit, Conception-Assist, Home Use
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Intimate Bridge 2 Conception, Inc. 3919 William Penn Hwy., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBB

Trailing 12 months

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

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