Cleared Traditional

Smart Alarm Interface (K193421) - FDA 510(k) Clearance

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

K193421 · Boxview, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
326d
Days
Class 2
Risk

K193421 is an FDA 510(k) clearance for the Smart Alarm Interface. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Boxview, LLC (Oklahoma City, US). The FDA issued a Cleared decision on October 30, 2020 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Boxview, LLC devices

Submission Details

510(k) Number K193421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date October 30, 2020
Days to Decision 326 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
201d slower than avg
Panel avg: 125d · This submission: 326d
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

Steurer Consulting Group
Robert Steurer

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 115
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K193421.
TigerConnect Alarm Management
K243270 · Tigerconnect · Sep 2025
BeneVision Central Monitoring System
K242728 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2025
Central Station
K242750 · Nihon Kohden Digital Health Solutions, LLC · Jun 2025
ANNE View, Central Hub
K242842 · Sibel Health, Inc. · Jan 2025
Hinscope
K241397 · Hinlab Sas · Nov 2024
Infinity Gateway Suite
K233834 · Draeger Medical Systems, Inc. · Jul 2024