Cleared Traditional

K861188 - SPERM CAPACITATION MEDIUM

K861188 is an FDA 510(k) clearance for SPERM CAPACITATION MEDIUM, manufactured by Irvine Scientific. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K861188 · Irvine Scientific · Obstetrics & Gynecology device
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Jan 1987
Decision
281d
Days
Class 2
Risk

K861188 is an FDA 510(k) clearance for the SPERM CAPACITATION MEDIUM. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Irvine Scientific (Laguna Hills, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 281 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.

FDA 510(k) Submission Details - K861188

510(k) Number K861188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date January 06, 1987
Days to Decision 281 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 161d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDR Device Classification - Class 2, Special Controls

Product Code HDR Cap, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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.

Regulatory Peers - HDR Cap, Cervical

All 27
Devices cleared under the same product code (HDR) and FDA review panel - the closest regulatory comparables to K861188.
SPERM WASHING MEDIUM #9932
K872102 · Irvine Scientific · Jul 1987
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
K871577 · Irvine Scientific · Jul 1987
INTRAUTERINE INSEMINATION CATHETER
K870551 · Cook Ob/Gyn · Mar 1987
INTRAUTERINE CATHETER
K861305 · Ram Development · Dec 1986
MAKLER CATHETER
K863785 · I M, Inc. · Dec 1986
AXISONIC II
K810697 · Teknar, Inc. · Jul 1981
K861188 · SPERM CAPACITATION MEDIUM
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