Cleared Traditional

K884696 - RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET

K884696 is an FDA 510(k) clearance for RESUBMITTED ARTIFICIAL INSEMINATION INS..., manufactured by Laboratoire Ccd C/O Washington Regulatory Services. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K884696 · Laboratoire Ccd C/O Washington Regulatory Services · Obstetrics & Gynecology device
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Jan 1989
Decision
79d
Days
Class 2
Risk

K884696 is an FDA 510(k) clearance for the RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Laboratoire Ccd C/O Washington Regulatory Services (Ringoes, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 79 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 Laboratoire Ccd C/O Washington Regulatory Services devices

FDA 510(k) Submission Details - K884696

510(k) Number K884696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1988
Decision Date January 27, 1989
Days to Decision 79 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
81d faster than avg
Panel avg: 160d · This submission: 79d
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 K884696.
SPERM SELECT SYSTEM
K900308 · Pharmacia, Inc. · Apr 1990
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