Cleared Traditional

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (K172011) - FDA 510(k) Clearance

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

K172011 · Hmicro, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
346d
Days
Class 2
Risk

K172011 is an FDA 510(k) clearance for the LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & .... Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Hmicro, Inc. (Fremont, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 346 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 Hmicro, Inc. devices

Submission Details

510(k) Number K172011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date June 14, 2018
Days to Decision 346 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
221d slower than avg
Panel avg: 125d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Lifesignals, Inc.
Saravanan Balasubramanlan

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 57
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K172011.
Surveyor S2
K182297 · Mortara Instrument, Inc. · Jan 2019
Comarch e-Care Platform
K181248 · Comarch Healthcare SA · Oct 2018
Caretaker Remote Display App and Caretaker Software Library
K181196 · Caretaker Medical, LLC · Oct 2018
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