Cleared Traditional

K200856 - SmartLinx Vitals Plus Patient Monitorin...

K200856 is an FDA 510(k) clearance for SmartLinx Vitals Plus Patient Monitorin..., manufactured by Capsule Technologie Sas. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K200856 · Capsule Technologie Sas · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
100d
Days
Class 2
Risk

K200856 is an FDA 510(k) clearance for the SmartLinx Vitals Plus Patient Monitoring System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Capsule Technologie Sas (Andover, US). The FDA issued a Cleared decision on July 10, 2020 after a review of 100 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 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 Capsule Technologie Sas devices

FDA 510(k) Submission Details - K200856

510(k) Number K200856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date July 10, 2020
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 151
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K200856.
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
K202892 · Edan Instruments, Inc. · Jan 2021
T3 Platform software
K202306 · Etiometry, Inc. · Nov 2020
Masimo Rad-97 Pulse CO-Oximeter and Accessories
K193626 · Masimo Corporation · Aug 2020
Oxi-W System
K200141 · Ld Technology, LLC · Apr 2020
Masimo Centroid System
K191882 · Masimo Corporation · Apr 2020
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
K193242 · Masimo Corporation · Feb 2020