Cleared Traditional

K103589 - NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103589 · Natus Medical Incorporated · General Hospital
May 2011
Decision
157d
Days
Class 2
Risk

K103589 is an FDA 510(k) clearance for the NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Natus Medical Incorporated (Seattle, US). The FDA issued a Cleared decision on May 13, 2011 after a review of 157 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K103589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2010
Decision Date May 13, 2011
Days to Decision 157 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 169d · This submission: 157d
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.