Cleared Traditional

Vital Sign Monitoring Sensor (Model :XK300) (K202464) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202464 · Xandar Kardian, Inc. · Cardiovascular device
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Apr 2021
Decision
242d
Days
Class 2
Risk

K202464 is an FDA 510(k) clearance for the Vital Sign Monitoring Sensor (Model :XK300). Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Xandar Kardian, Inc. (Seoul, KR). The FDA issued a Cleared decision on April 26, 2021 after a review of 242 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 Xandar Kardian, Inc. devices

Submission Details

510(k) Number K202464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2020
Decision Date April 26, 2021
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 Consultant

Alira Health
Brennan Sullivan

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.

Regulatory Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 72
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K202464.
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K181165 · Connected Sensing- A Division of Philips Medical Systems · Mar 2019
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K172586 · Vios Medical, Inc. · Jun 2018
12 RL ALGORITHM
K060307 · Ge Medical Systems Information Technologies · Aug 2006