Cleared Traditional

K872088 - FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)

K872088 is an FDA 510(k) clearance for FREEZING MEDIUM (TEST YOLK BUFFER W/GLY..., 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 74-day FDA review.

K872088 · Irvine Scientific · Obstetrics & Gynecology device
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Aug 1987
Decision
74d
Days
Class 2
Risk

K872088 is an FDA 510(k) clearance for the FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL). Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on August 14, 1987 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Irvine Scientific devices

FDA 510(k) Submission Details - K872088

510(k) Number K872088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date August 14, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 160d · This submission: 74d
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 15
Devices cleared under the same product code (HDR) and FDA review panel - the closest regulatory comparables to K872088.
DGH A-SAN PROBE HOLDER
K900162 · Jedmed Instrument Co. · Feb 1990
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301 · Cook Ob/Gyn · Mar 1989
SPERM-SELECT ADDITIONAL INDICATION
K872849 · Pharmacia, Inc. · Sep 1987
INTRAUTERINE INSEMINATION CATHETER
K870551 · Cook Ob/Gyn · Mar 1987
MAKLER CATHETER
K863785 · I M, Inc. · Dec 1986
AXISONIC II
K810697 · Teknar, Inc. · Jul 1981