Cleared Abbreviated

K152645 - Dictum Health

K152645 is an FDA 510(k) clearance for Dictum Health, manufactured by Dictum Health, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Abbreviated 510(k) pathway after a 146-day FDA review.

K152645 · Dictum Health, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2016
Decision
146d
Days
Class 2
Risk

K152645 is an FDA 510(k) clearance for the Dictum Health. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Dictum Health, Inc. (Oakland, US). The FDA issued a Cleared decision on February 9, 2016 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dictum Health, Inc. devices

FDA 510(k) Submission Details - K152645

510(k) Number K152645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2015
Decision Date February 09, 2016
Days to Decision 146 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Standards-based clearance path.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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