Cleared Traditional

K871385 - MODEL U-1000 WITH GESTATIONAL AGE CALCU...

K871385 is the FDA 510(k) clearance for MODEL U-1000 WITH GESTATIONAL AGE CALCU... by Fukuda Denshi USA, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K871385 · Fukuda Denshi USA, Inc. · Obstetrics & Gynecology device
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May 1987
Decision
49d
Days
Class 2
Risk

K871385 is an FDA 510(k) clearance for the MODEL U-1000 WITH GESTATIONAL AGE CALCULATION. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 49 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 Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K871385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date May 26, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 160d · This submission: 49d
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 97
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K871385.
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FETALERT ADR FETAL MONITOR
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OMF-7101 FETAL MONITOR
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MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · Hewlett-Packard Co. · Jul 1986
TECNOL SECURE-ALL FETAL MONITOR STRAP
K861189 · Tecnol New Jersey Wound Care, Inc. · Apr 1986