Cleared Traditional

K180430 - Digistat Smart Central

K180430 is the FDA 510(k) clearance for Digistat Smart Central by Ascom Ums Srl Unipersonale. It is a Class 2 Cardiovascular device (product code MSX) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K180430 · Ascom Ums Srl Unipersonale · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
280d
Days
Class 2
Risk

K180430 is an FDA 510(k) clearance for the Digistat Smart Central. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Ascom Ums Srl Unipersonale (Scandicci (Fi), IT). The FDA issued a Cleared decision on November 23, 2018 after a review of 280 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 Ascom Ums Srl Unipersonale devices

Submission Details

510(k) Number K180430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2018
Decision Date November 23, 2018
Days to Decision 280 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
155d slower than avg
Panel avg: 125d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Speed TO Market, Inc.
Thomas Kroenke

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 - MSX System, Network And Communication, Physiological Monitors

All 69
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K180430.
Philips IntelliVue XDS Software
K182637 · Philips Medizin Systeme Boeblingen GmbH · Apr 2019
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
K190073 · Current Health , Ltd. · Mar 2019
BeneVision Central Monitoring System
K183238 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2019
Wearable Device
K182543 · Snap40, Ltd. · Nov 2018
Unite Connect for Clinical Systems
K180566 · Ascom (Sweden) AB · Apr 2018
Athena GTX Device Management Suite (ADMS) Software
K173203 · Athena Gtx · Mar 2018