Cleared Traditional

K163694 - Rooti Rx ECG Event Recorder

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
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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.

View all Rooti Labs , Ltd. devices

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
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 75
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
FFR Link, FFR Signal Processing Module
K170204 · Boston Scientific Corporation · Mar 2017
TelePatch Cardiac Monitor
K161916 · Medicomp, Inc. · Dec 2016
SURVEYOR S4 MOBILE MONITOR
K141020 · Mortara Instrument, Inc. · Dec 2014