Cleared Traditional

K902802 - FETAL MONITORING TRANSDUCER STRAP

K902802 is the FDA 510(k) clearance for FETAL MONITORING TRANSDUCER STRAP by Macon & Co., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K902802 · Macon & Co., Inc. · Obstetrics & Gynecology device
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Sep 1990
Decision
88d
Days
Class 2
Risk

K902802 is an FDA 510(k) clearance for the FETAL MONITORING TRANSDUCER STRAP. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Macon & Co., Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 4, 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 884.2740 - 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 Macon & Co., Inc. devices

Submission Details

510(k) Number K902802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date September 04, 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.

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 K902802.
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