Cleared Special

K082366 - LIFEBED PATIENT VIGILANCE SYSTEM

K082366 is an FDA 510(k) clearance for LIFEBED 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 39-day FDA review.

K082366 · Hoana Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
39d
Days
Class 2
Risk

K082366 is an FDA 510(k) clearance for the LIFEBED PATIENT 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 September 26, 2008 after a review of 39 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.

FDA 510(k) Submission Details - K082366

510(k) Number K082366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date September 26, 2008
Days to Decision 39 days
Submission Type Special
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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 250
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K082366.
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K082366 · LIFEBED PATIENT VIGILANCE SYSTEM
Download PDF FDA Summary Hoana Medical, Inc.