Cleared Traditional

K202497 - Aulisa Multiple Patient Digital Vital Sign Monitoring System

K202497 is an FDA 510(k) clearance for Aulisa Multiple Patient Digital Vital S..., manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K202497 · Taiwan Aulisa Medical Devices Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
60d
Days
Class 2
Risk

K202497 is an FDA 510(k) clearance for the Aulisa Multiple Patient Digital Vital Sign Monitoring System. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on October 30, 2020 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Taiwan Aulisa Medical Devices Technologies, Inc. devices

FDA 510(k) Submission Details - K202497

510(k) Number K202497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2020
Decision Date October 30, 2020
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
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 - MSX System, Network And Communication, Physiological Monitors

All 118
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K202497.
AlertWatch:AC
K210160 · Alertwatch, Inc. · Sep 2021
Current Health Monitoring System Gen 2 (G2)
K210133 · Current Health · Sep 2021
Smart Alarm Interface
K193421 · Boxview, LLC · Oct 2020
Spire Health Remote Patient Monitoring System
K192952 · Spire, Inc. D/B/A Spire Health · Jun 2020
BeneVision Central Monitoring System
K193391 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2020
Critical Alert CommonPath Enterprise
K193043 · Critical Alert · May 2020