Cleared Traditional

K760919 - MODEL 2106 FETA SONDE FETAL MONITOR

K760919 is the FDA 510(k) clearance for MODEL 2106 FETA SONDE FETAL MONITOR by Roche Medical Electronics, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K760919 · Roche Medical Electronics, Inc. · Obstetrics & Gynecology device
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Nov 1976
Decision
19d
Days
Class 2
Risk

K760919 is an FDA 510(k) clearance for the MODEL 2106 FETA SONDE FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Roche Medical Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1976 after a review of 19 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.

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Submission Details

510(k) Number K760919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1976
Decision Date November 16, 1976
Days to Decision 19 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
141d faster than avg
Panel avg: 160d · This submission: 19d
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.