Cleared Traditional

K901593 - IMEX DOP-TONE II

K901593 is an FDA 510(k) clearance for IMEX DOP-TONE II, manufactured by Imex 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 88-day FDA review.

K901593 · Imex Medical Systems, Inc. · Obstetrics & Gynecology device
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Jul 1990
Decision
88d
Days
Class 2
Risk

K901593 is an FDA 510(k) clearance for the IMEX DOP-TONE II. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on July 2, 1990 after a review of 88 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 Imex Medical Systems, Inc. devices

FDA 510(k) Submission Details - K901593

510(k) Number K901593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1990
Decision Date July 02, 1990
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 26
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K901593.
OB1 OBSTETRICAL DOPPLER
K033156 · D. E. Hokanson, Inc. · Dec 2003
CADENCE DOPPLER ULTRASOUND SYSTEM
K991441 · Medasonics, Inc. · Dec 1999
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991
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