Cleared Traditional

K233133 - Talis EMR with Talis +ACG (Talis EMR wi...

K233133 is an FDA 510(k) clearance for Talis EMR with Talis +ACG (Talis EMR wi..., manufactured by Talis Clinical, LLC. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K233133 · Talis Clinical, LLC · Cardiovascular device
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Apr 2024
Decision
187d
Days
Class 2
Risk

K233133 is an FDA 510(k) clearance for the Talis EMR with Talis +ACG (Talis EMR with +ACG). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Talis Clinical, LLC (Streetsboro, US). The FDA issued a Cleared decision on April 1, 2024 after a review of 187 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 Talis Clinical, LLC devices

FDA 510(k) Submission Details - K233133

510(k) Number K233133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date April 01, 2024
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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)

All 159
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