Cleared Special

K100745 - LIFEBED NETWORK PATIENT VIGILANCE SYSTEM

K100745 is an FDA 510(k) clearance for LIFEBED NETWORK PATIENT VIGILANCE SYSTEM, manufactured by Hoana Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Special 510(k) pathway after a 30-day FDA review.

K100745 · Hoana Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
30d
Days
Class 2
Risk

K100745 is an FDA 510(k) clearance for the LIFEBED NETWORK PATIENT VIGILANCE SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Hoana Medical, Inc. (Renton, US). The FDA issued a Cleared decision on April 15, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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.

View all Hoana Medical, Inc. devices

FDA 510(k) Submission Details - K100745

510(k) Number K100745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2010
Decision Date April 15, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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
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