Cleared Special

K080752 - CONCEIVEX LATEX-FREE SEMEN COLLECTOR

K080752 is an FDA 510(k) clearance for CONCEIVEX LATEX-FREE SEMEN COLLECTOR, manufactured by Conceivex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code OBB cleared through the Special 510(k) pathway after a 58-day FDA review.

K080752 · Conceivex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
58d
Days
Class 2
Risk

K080752 is an FDA 510(k) clearance for the CONCEIVEX LATEX-FREE SEMEN COLLECTOR. Classified as Kit, Conception-assist, Home Use (product code OBB), Class II - Special Controls.

Submitted by Conceivex, Inc. (Mt. Airy, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080752

510(k) Number K080752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date May 14, 2008
Days to Decision 58 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 161d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

OBB Device Classification - Class 2, Special Controls

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.

K080752 · CONCEIVEX LATEX-FREE SEMEN COLLECTOR
Download PDF FDA Summary Conceivex, Inc.