Cleared Traditional

K081499 - HEALTH MANAGER

K081499 is the FDA 510(k) clearance for HEALTH MANAGER by Biocomfort Diagnostics GmbH & Co. KG. It is a Class 2 Cardiovascular device (product code DRG) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K081499 · Biocomfort Diagnostics GmbH & Co. KG · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2009
Decision
232d
Days
Class 2
Risk

K081499 is an FDA 510(k) clearance for the HEALTH MANAGER, VERSION 1.1. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Biocomfort Diagnostics GmbH & Co. KG (Neuhausen A.D.F., DE). The FDA issued a Cleared decision on January 16, 2009 after a review of 232 days - an extended review cycle.

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.

View all Biocomfort Diagnostics GmbH & Co. KG devices

Submission Details

510(k) Number K081499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2008
Decision Date January 16, 2009
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
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