Cleared Traditional

K130056 - PATIENT MONITOR

K130056 is an FDA 510(k) clearance for PATIENT MONITOR, manufactured by Ld Technology, LLC. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K130056 · Ld Technology, LLC · Cardiovascular device
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Apr 2013
Decision
92d
Days
Class 2
Risk

K130056 is an FDA 510(k) clearance for the PATIENT MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on April 11, 2013 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Ld Technology, LLC devices

FDA 510(k) Submission Details - K130056

510(k) Number K130056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2013
Decision Date April 11, 2013
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K130056.
740 SELECT
K130411 · Cas Medical Systems, Inc. · May 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K130796 · Covidien · May 2013
WVSM (WIRLESS VITAL SIGNS MONITOR)
K130957 · Athena Gtx · Apr 2013
NUVON VITALS CHARTING SYSTEM
K130234 · Nuvon, Inc. · Mar 2013
VITAL SYNC SYSTEM
K123002 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Feb 2013
MRI PATIENT MONITORING SYSTEM (MODEL 865214)
K124061 · Invivo Corporation · Feb 2013