Cleared Traditional

K881414 - CERVICATH

K881414 is an FDA 510(k) clearance for CERVICATH, manufactured by Epcom Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K881414 · Epcom Medical Systems, Inc. · Obstetrics & Gynecology device
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Jun 1988
Decision
71d
Days
Class 2
Risk

K881414 is an FDA 510(k) clearance for the CERVICATH. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Epcom Medical Systems, Inc. (Livermore, US). The FDA issued a Cleared decision on June 14, 1988 after a review of 71 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 Epcom Medical Systems, Inc. devices

FDA 510(k) Submission Details - K881414

510(k) Number K881414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date June 14, 1988
Days to Decision 71 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
89d faster than avg
Panel avg: 160d · This submission: 71d
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 K881414.
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