Cleared Traditional

Biovitals Analytics Engine (K183282) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K183282 · Biofourmis Singapore Pte., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
262d
Days
Class 2
Risk

K183282 is an FDA 510(k) clearance for the Biovitals Analytics Engine. Classified as Multivariate Vital Signs Index (product code PLB), Class II - Special Controls.

Submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 15, 2019 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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. Standard predicate reliance. 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 Biofourmis Singapore Pte., Ltd. devices

Submission Details

510(k) Number K183282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2018
Decision Date August 15, 2019
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PLB Multivariate Vital Signs Index
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
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.

Regulatory Consultant

Rakesh Lal
Rakesh Lal

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.

Clinical Evidence

ClinicalTrials.gov
NCT02391987 Completed Interventional

Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure

A Randomized Study of the Effectiveness of an Integrated Tele-monitoring and Patient-centric Health Coaching Strategy (Tele-HC) in Adult Patients Recently Hospitalized With Acute Decompensated Heart Failure (ADHF) Compared to Standard Care

112
Patients (actual)
5
Sites
Supportive_care
Purpose
Open label
Masking
Condition studied Heart Failure
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Charles Bruce, MD
Sponsor Mayo Clinic
Started 2015-05-01 → Primary completion 2019-03-01
Primary outcome
Hospital Readmission
Secondary outcome
Number of Readmissions or Visits
View full study on ClinicalTrials.gov