Cleared Traditional

K852704 - TWEETHEART #102 FETAL/NEONATAL HEARTBEA...

K852704 is the FDA 510(k) clearance for TWEETHEART #102 FETAL/NEONATAL HEARTBEA... by Clincal Instruments Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K852704 · Clincal Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
153d
Days
Class 2
Risk

K852704 is an FDA 510(k) clearance for the TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Clincal Instruments Corp. (Cleveland, US). The FDA issued a Cleared decision on November 26, 1985 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clincal Instruments Corp. devices

Submission Details

510(k) Number K852704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date November 26, 1985
Days to Decision 153 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
7d faster than avg
Panel avg: 160d · This submission: 153d
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 K852704.
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986
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
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
K852608 · Ge Medical Systems Information Technologies · Sep 1985
KONTRON FAX FETAL MONITOR
K842422 · Kontron Instruments, Inc. · Sep 1985
MODEL 145 FETAL MONITOR
K852076 · Ge Medical Systems Information Technologies · Jul 1985