Cleared Traditional

FOCUS TOUCH CONCEPTION SYSTEM (K112200) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112200 · Intimate Bridge 2 Conception, Inc. · Obstetrics & Gynecology device
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Sep 2012
Decision
402d
Days
Class 2
Risk

K112200 is an FDA 510(k) clearance for the FOCUS TOUCH CONCEPTION SYSTEM. Classified as Kit, Conception-assist, Home Use (product code OBB), Class II - Special Controls.

Submitted by Intimate Bridge 2 Conception, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Intimate Bridge 2 Conception, Inc. devices

Submission Details

510(k) Number K112200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2011
Decision Date September 06, 2012
Days to Decision 402 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 160d · This submission: 402d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBB Kit, Conception-assist, Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
Definition 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 As An Aid To Conception. It Is To Be Used At Home Following Physician Instruction. The Cap Should Not Be Left In Place For More Than 6 Hours. The Kit Consists Of: Conception (cervical) Caps; 3 Polyurethane Condoms; 24 Ovulation Predictors; 3 Pregnancy Test Kits; 3 "sperm Friendly" Moisturizer Samples (pre Lubricant); 1 Conception Journal; 1 Instruction Manual; 2 Conception Wheels (1 In English And 1 In French); 1 Medical Provider Envelope.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.