Cleared Traditional

K132918 - SENSE-4BABY SYSTEM

K132918 is an FDA 510(k) clearance for SENSE-4BABY SYSTEM, manufactured by Sense4baby , Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K132918 · Sense4baby , Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
66d
Days
Class 2
Risk

K132918 is an FDA 510(k) clearance for the SENSE-4BABY SYSTEM. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Sense4baby , Inc. (La Jolla, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 66 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.

FDA 510(k) Submission Details - K132918

510(k) Number K132918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2013
Decision Date November 22, 2013
Days to Decision 66 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 161d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HGM Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 185
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K132918.
FM-3000 FETAL MONITOR
K141194 · Advanced Instrumentations, Inc. · Nov 2014
FETAL MONITORS
K131941 · Guangdong Biolight Meditech Co., Ltd. · May 2014
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
K132650 · Huntleigh Healthcare Limited · Feb 2014
SUNRAY FETAL MONITOR
K123335 · Sunray Medical Apparatus Co., Ltd. · Mar 2013
CERNER FETALINK+(VERSION1.0)
K121758 · Cerner Corp. · Oct 2012
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
K120018 · Mindchild Medical · Sep 2012

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.