Cleared Traditional

K051869 - NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

K051869 is the FDA 510(k) clearance for NEOBLUE COZY LED PHOTOTHERAPY SYSTEM by Natus Medical, Inc.. It is a Class 2 General Hospital device (product code LBI) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K051869 · Natus Medical, Inc. · General Hospital
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Oct 2005
Decision
88d
Days
Class 2
Risk

K051869 is an FDA 510(k) clearance for the NEOBLUE COZY LED PHOTOTHERAPY SYSTEM. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Natus Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - the FDA general hospital device 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 Natus Medical, Inc. devices

Submission Details

510(k) Number K051869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2005
Decision Date October 07, 2005
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
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 General Hospital devices follow this clearance model.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 20
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K051869.
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