Cleared Traditional

K872849 - SPERM-SELECT ADDITIONAL INDICATION

K872849 is an FDA 510(k) clearance for SPERM-SELECT ADDITIONAL INDICATION, manufactured by Pharmacia, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K872849 · Pharmacia, Inc. · Obstetrics & Gynecology device
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Sep 1987
Decision
70d
Days
Class 2
Risk

K872849 is an FDA 510(k) clearance for the SPERM-SELECT ADDITIONAL INDICATION. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on September 28, 1987 after a review of 70 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 - K872849

510(k) Number K872849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1987
Decision Date September 28, 1987
Days to Decision 70 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
91d faster than avg
Panel avg: 161d · This submission: 70d
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 28
Devices cleared under the same product code (HDR) and FDA review panel - the closest regulatory comparables to K872849.
RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET
K884696 · Laboratoire Ccd C/O Washington Regulatory Services · Jan 1989
CERVICATH
K881414 · Epcom Medical Systems, Inc. · Jun 1988
SPERM WASHING MEDIUM #9983 & MODIFIED #9984
K874668 · Irvine Scientific · Mar 1988
FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)
K872088 · Irvine Scientific · Aug 1987
CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)
K872203 · Irvine Scientific · Aug 1987
SPERM WASHING MEDIUM #9932
K872102 · Irvine Scientific · Jul 1987
K872849 · SPERM-SELECT ADDITIONAL INDICATION
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