Cleared Traditional

K841805 - OBSTETRICAL DOPPLER

K841805 is an FDA 510(k) clearance for OBSTETRICAL DOPPLER, manufactured by Epcom Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K841805 · Epcom Medical Systems, Inc. · Obstetrics & Gynecology device
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Jun 1984
Decision
49d
Days
Class 2
Risk

K841805 is an FDA 510(k) clearance for the OBSTETRICAL DOPPLER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Epcom Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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 - K841805

510(k) Number K841805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date June 19, 1984
Days to Decision 49 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
111d faster than avg
Panel avg: 160d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - KNG Monitor, Ultrasonic, Fetal

All 40
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K841805.
IMEX DOP-TONE II
K901593 · Imex Medical Systems, Inc. · Jul 1990
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618 · Huntleigh Technology, Inc. · Apr 1990
HUNTLEIGH DOPCORD, D140
K854267 · Huntleigh Technology, Inc. · Jul 1986
PROGRAMALITH PROGRAMMER
K823242 · Pacesetter Systems · Jan 1983
DOPPLEX-PLB & PXB
K810115 · Huntleigh Technology, Inc. · Jul 1981
FETAL HEART DETECTOR #'S D102 & D102R
K800858 · Sonicaid, Inc. · May 1980