Cleared Traditional

K140186 - THE STORK OTC

K140186 is an FDA 510(k) clearance for THE STORK OTC, manufactured by Rinovum Women'S Health, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code OBB cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K140186 · Rinovum Women'S Health, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
168d
Days
Class 2
Risk

K140186 is an FDA 510(k) clearance for the THE STORK OTC. Classified as Kit, Conception-assist, Home Use (product code OBB), Class II - Special Controls.

Submitted by Rinovum Women'S Health, Inc. (Monroeville, US). The FDA issued a Cleared decision on July 11, 2014 after a review of 168 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rinovum Women'S Health, Inc. devices

FDA 510(k) Submission Details - K140186

510(k) Number K140186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2014
Decision Date July 11, 2014
Days to Decision 168 days
Submission Type Traditional
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
7d slower than avg
Panel avg: 161d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02038322 Completed Interventional Industry-sponsored

The Stork OTC: Collection, Placement & Delivery

The Stork™ Conception System (OTC) Clinical Trial: Semen Collection, Placement and Delivery

53
Patients (actual)
1
Site
Open label
Masking
Condition studied Safety and Usability
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Michael J Pelekanos, OB-GYN
Sponsor Rinovum Women's Health, Inc. (industry)
Started 2013-07-01 → Primary completion 2014-01-01
Primary outcome
Efficacy -Primary endpoint part 1 - Collection
Secondary outcome
Secondary Endpoint
Study completed - no results published. This trial concluded in 2014 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov