Cleared Traditional

K053112 - BIOSIGN

K053112 is an FDA 510(k) clearance for BIOSIGN, manufactured by Oxford Biosignals Limited. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K053112 · Oxford Biosignals Limited · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
88d
Days
Class 2
Risk

K053112 is an FDA 510(k) clearance for the BIOSIGN. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Oxford Biosignals Limited (Washington, US). The FDA issued a Cleared decision on January 31, 2006 after a review of 88 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 Oxford Biosignals Limited devices

FDA 510(k) Submission Details - K053112

510(k) Number K053112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2005
Decision Date January 31, 2006
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 194
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