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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 161d · 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 27
Devices cleared under the same product code (HDR) and FDA review panel - the closest regulatory comparables to K872088.
CERVICATH
K881414 · Epcom Medical Systems, Inc. · Jun 1988
SPERM WASHING MEDIUM #9983 & MODIFIED #9984
K874668 · Irvine Scientific · Mar 1988
SPERM-SELECT ADDITIONAL INDICATION
K872849 · Pharmacia, Inc. · Sep 1987
CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)
K872203 · Irvine Scientific · Aug 1987
SPERM WASHING MEDIUM #9932
K872102 · Irvine Scientific · Jul 1987
HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES
K871577 · Irvine Scientific · Jul 1987
K872088 · FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)
Download PDF Irvine Scientific