Cleared Traditional

K120470 - MIPAL

K120470 is an FDA 510(k) clearance for MIPAL, manufactured by Watermark Medical. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K120470 · Watermark Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K120470

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
Combination Product No
PCCP Authorized No
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.

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 K120470.
VIGNET TELEHEALTH MANAGER
K113446 · Vignet, Inc. · Jul 2012
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
K120253 · Elcam Medical Acal · Jul 2012
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
K120941 · Constant Care, LLC · Jul 2012
REMOTE PRESENCE SYSTEM
K120895 · Intouch Health, Inc. · May 2012
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
K120704 · 3M Company · May 2012
GENESIS TOUCH SYSTEM
K112858 · Honeywell Hommed, LLC · Jan 2012
K120470 · MIPAL
Download PDF FDA Summary Watermark Medical