Cleared Special

K163535 - my Patch sl

K163535 is an FDA 510(k) clearance for my Patch sl, manufactured by Dms-Service, LLC. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Special 510(k) pathway after a 68-day FDA review.

K163535 · Dms-Service, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
68d
Days
Class 2
Risk

K163535 is an FDA 510(k) clearance for the my Patch sl. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Dms-Service, LLC (Los Angeles, US). The FDA issued a Cleared decision on February 22, 2017 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K163535

510(k) Number K163535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date February 22, 2017
Days to Decision 68 days
Submission Type Special
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
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 134
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K163535.
ePatch
K171410 · Braemar Manufacturing, LLC · Jan 2018
Peerbridge Cor(TM) System
K171936 · Peerbridge Health, Inc. · Sep 2017
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
K162503 · Cardiac Insight, Inc. · Mar 2017
Bioflux Software
K162571 · Biotricity, Inc. · Oct 2016
myPatch-s
K160704 · Dms-Service, LLC · Jul 2016
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
K142468 · Cardiac Insight, Inc. · Jul 2015