Cleared Traditional

K120470 - MIPAL (FDA 510(k) Clearance)

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

K120470 · Watermark Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
113d
Days
Class 2
Risk

K120470 is an FDA 510(k) clearance for the MIPAL. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Watermark Medical (Brookfield, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 113 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Watermark Medical devices

Submission Details

510(k) Number K120470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2012
Decision Date June 08, 2012
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 190
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K120470.
Perin Health System (PHD80060-2)
K252984 · Perin Health Devices, LLC · Jan 2026
EasyTeleMed (2.0.2)
K252440 · Ingeniars S.R.L. · Oct 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259 · The ScottCare Corporation · Jun 2025
iBSM
K243837 · Iorbit Digital Technologies Private Limited · May 2025
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · Lifesignals, Inc. · Nov 2024
BioButton System
K241101 · Biointellisense, Inc. · Sep 2024