Cleared Traditional

K052446 - LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM

K052446 is an FDA 510(k) clearance for LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM, manufactured by Hoana Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K052446 · Hoana Medical, Inc. · Cardiovascular device
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Feb 2006
Decision
148d
Days
Class 2
Risk

K052446 is an FDA 510(k) clearance for the LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Hoana Medical, Inc. (Honolulu, US). The FDA issued a Cleared decision on February 2, 2006 after a review of 148 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 Hoana Medical, Inc. devices

FDA 510(k) Submission Details - K052446

510(k) Number K052446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date February 02, 2006
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 205
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K052446.
506CN PATIENT MONITOR
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K060307 · Ge Medical Systems Information Technologies · Aug 2006
TRANSMITTER, ZS-940PA SERIES
K043517 · Nihon Kohden America, Inc. · Feb 2005
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2004
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · Ivy Biomedical Systems, Inc. · Nov 2002