Cleared Traditional

K090801 - ELECTRONIC HOUSE CALL

K090801 is an FDA 510(k) clearance for ELECTRONIC HOUSE CALL, manufactured by Express MD Solutions, LLC. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K090801 · Express MD Solutions, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
15d
Days
Class 2
Risk

K090801 is an FDA 510(k) clearance for the ELECTRONIC HOUSE CALL. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Express MD Solutions, LLC (Palm Beach Gardens, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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.

FDA 510(k) Submission Details - K090801

510(k) Number K090801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2009
Decision Date April 08, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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

Intertek Testing Services
DANIEL W LEHTONEN

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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 185
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K090801.
MODIFICATION TO MEDICOMPASS CONNECT
K091021 · Imetrikus, Inc. · Jul 2009
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K083862 · Medapps, Inc. · Jun 2009
RTX 3371
K090886 · Tunstall Healthcare · Apr 2009
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610 · Hospira, Inc. · Mar 2009
HEALTH MANAGER, VERSION 1.1
K081499 · Biocomfort Diagnostics GmbH & Co. KG · Jan 2009
FORA TELEHEALTH SYSTEM
K083046 · Taidoc Technology Corporation · Jan 2009
K090801 · ELECTRONIC HOUSE CALL
Download PDF FDA Summary Express MD Solutions,…