Cleared Traditional

K082602 - FETAL & MATERNAL MONITOR

K082602 is the FDA 510(k) clearance for FETAL & MATERNAL MONITOR by Edan Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K082602 · Edan Instruments, Inc. · Obstetrics & Gynecology device
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Nov 2008
Decision
79d
Days
Class 2
Risk

K082602 is an FDA 510(k) clearance for the FETAL & MATERNAL MONITOR, MODEL F6, F9. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 79 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number K082602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date November 26, 2008
Days to Decision 79 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 160d · This submission: 79d
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 88
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K082602.
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · Edan Instruments, Inc. · Nov 2010
PHILIPS OBTRACEVUE MODEL SW REV. G.00
K100420 · Philips Medizin Systeme Boeblingen GmbH · Jul 2010
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
K092028 · Philips Medizin Systeme Boeblingen GmbH · Feb 2010
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · Edan Instruments, Inc. · Nov 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K081203 · Philips Medizin Systeme Boeblingen GmbH · May 2008
CADENCE II
K073221 · Edan Instruments, Inc. · Dec 2007