Cleared Traditional

K163694 - Rooti Rx ECG Event Recorder, Rooti Link APP Software

K163694 is an FDA 510(k) clearance for Rooti Rx ECG Event Recorder, manufactured by Rooti Labs , Ltd.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K163694 · Rooti Labs , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
314d
Days
Class 2
Risk

K163694 is an FDA 510(k) clearance for the Rooti Rx ECG Event Recorder, Rooti Link APP Software. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Rooti Labs , Ltd. (Taipei, TW). The FDA issued a Cleared decision on November 7, 2017 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

FDA 510(k) Submission Details - K163694

510(k) Number K163694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2016
Decision Date November 07, 2017
Days to Decision 314 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
189d slower than avg
Panel avg: 125d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 183
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K163694.
ScioCardio ECG Transmitter
K171019 · Synergen Technology Labs, LLC · May 2018
BioStamp nPoint
K173510 · Mc10, Inc. · May 2018
Patient Status Engine
K172329 · Isansys Lifecare, Ltd. · Apr 2018
VitalPatch® VitalConnect Platform
K163453 · Vitalconnect, Inc. · Nov 2017
Optum TeleHealth Application
K171406 · United Health Group, Inc. · Aug 2017
eCareCoordinator
K171029 · Visicu, Inc. · Jul 2017