Cleared Traditional

K761030 - EKOSECTOR I (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K761030 · Smithkline Diagnostics, Inc. · Obstetrics & Gynecology device
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Dec 1976
Decision
31d
Days
Class 2
Risk

K761030 is an FDA 510(k) clearance for the EKOSECTOR I. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1976 after a review of 31 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K761030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1976
Decision Date December 13, 1976
Days to Decision 31 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
129d faster than avg
Panel avg: 160d · This submission: 31d
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 213
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