Cleared Traditional

K761201 - ECHO-CARDIOTRACE

K761201 is the FDA 510(k) clearance for ECHO-CARDIOTRACE by Metrix Co.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K761201 · Metrix Co. · Obstetrics & Gynecology device
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Jan 1977
Decision
37d
Days
Class 2
Risk

K761201 is an FDA 510(k) clearance for the ECHO-CARDIOTRACE, AUTOMATIC. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Metrix Co. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1977 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - 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 Metrix Co. devices

Submission Details

510(k) Number K761201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1976
Decision Date January 12, 1977
Days to Decision 37 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
123d faster than avg
Panel avg: 160d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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 - HGM System, Monitoring, Perinatal

All 98
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K761201.
FETAL/MATERNAL ALRM MODULE - 21595A
K771194 · Hewlett-Packard Co. · Aug 1977
FETAL/MATERNAL REPEATER - 21596A
K771195 · Hewlett-Packard Co. · Aug 1977
MARKER GENERATOR MODULES - 21597A
K771196 · Hewlett-Packard Co. · Aug 1977
T-M (TIME-MOTION) OPTION
K761139 · G.D. Searle and Co. · Dec 1976
EKOSECTOR I
K761030 · Smithkline Diagnostics, Inc. · Dec 1976