Cleared Traditional

K071606 - BIOSIGN CENTRAL STATION

K071606 is an FDA 510(k) clearance for BIOSIGN CENTRAL STATION, manufactured by Obs Medical. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K071606 · Obs Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
80d
Days
Class 2
Risk

K071606 is an FDA 510(k) clearance for the BIOSIGN CENTRAL STATION. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Obs Medical (Carmel, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Obs Medical devices

FDA 510(k) Submission Details - K071606

510(k) Number K071606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2007
Decision Date August 31, 2007
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 179
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K071606.
STAR 55
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K063055 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2006
MODIFICATION TO MODEL 750 SERIES MONITOR
K063087 · Cas Medical Systems, Inc. · Dec 2006