Cleared Traditional

K132173 - FAMILY HEALTHWARE

K132173 is an FDA 510(k) clearance for FAMILY HEALTHWARE, manufactured by Sanitas, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K132173 · Sanitas, Inc. · Cardiovascular device
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May 2014
Decision
319d
Days
Class 2
Risk

K132173 is an FDA 510(k) clearance for the FAMILY HEALTHWARE. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Sanitas, Inc. (San Diego, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sanitas, Inc. devices

FDA 510(k) Submission Details - K132173

510(k) Number K132173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date May 30, 2014
Days to Decision 319 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 125d · This submission: 319d
Pathway characteristics
Predicate-based equivalence.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00164658 Completed Interventional

Evaluating Tools for Health Promotion and Disease Prevention

8400
Patients (est.)
3
Sites
Prevention
Purpose
Single blind
Masking
Condition studied Coronary Heart Disease; Stroke; Diabetes; Breast Cancer; Ovarian Cancer; Colorectal Cancer
Study design Parallel
Eligibility All sexes · 35 Years+ · Healthy volunteers accepted
Principal investigator Louise S Acheson, MD, MS
Sponsor Centers for Disease Control and Prevention
Started 2005-09-01 → Completed 2007-10-01
Primary outcome
Change in stage of adoption of health behaviors and referral for additional screening and follow up for high risk participants at 6 month post evaluation
Secondary outcome
Primary care physicians' provision of preventive services in response to family medical history.
Study completed - no results published. This trial concluded in 2007 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 178
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K132173.
LG SMARTHEALTH
K133997 · Lg Electronics · Nov 2014
ECARE COORDINATOR (ECC)
K141706 · Visicu, Inc. · Sep 2014
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
K141167 · Vitalconnect, Inc. · Jul 2014
MYHEALTHPOINT TELEHEALTH MANAGER
K132930 · Entra Health Systems · Apr 2014
VITALCONNECT PLATFORM BY VITAL CONNECT INC.
K132447 · Vitalconnect, Inc. · Apr 2014
HEALTHINTERLINK BEACON
K133252 · Healthinterlink, LLC · Mar 2014