Cleared Traditional

K142512 - Personalized Physiology Analytics Engin...

K142512 is an FDA 510(k) clearance for Personalized Physiology Analytics Engin..., manufactured by Vgbio, Inc (Dba Physiq). The device is a Class 2 Cardiovascular device with product code PLB cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K142512 · Vgbio, Inc (Dba Physiq) · Cardiovascular device
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Jun 2015
Decision
276d
Days
Class 2
Risk

K142512 is an FDA 510(k) clearance for the Personalized Physiology Analytics Engine software. Classified as Multivariate Vital Signs Index (product code PLB), Class II - Special Controls.

Submitted by Vgbio, Inc (Dba Physiq) (Naperville, US). The FDA issued a Cleared decision on June 11, 2015 after a review of 276 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 Vgbio, Inc (Dba Physiq) devices

FDA 510(k) Submission Details - K142512

510(k) Number K142512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date June 11, 2015
Days to Decision 276 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 125d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLB Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.