Cleared Traditional

K160305 - neoBLUE® LED Phototherapy System

K160305 is an FDA 510(k) clearance for neoBLUE LED Phototherapy System, manufactured by Natus Medical Incorporated. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K160305 · Natus Medical Incorporated · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
113d
Days
Class 2
Risk

K160305 is an FDA 510(k) clearance for the neoBLUE® 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 27, 2016 after a review of 113 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K160305

510(k) Number K160305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2016
Decision Date May 27, 2016
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBI Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K160305.
Bilicocoon™ Phototherapy System
K163526 · Neomedlight · Oct 2017
neoBLUE compact LED Phototherapy System
K160745 · Natus Medical Incorporated · Dec 2016
Airborne Phototherapy Light
K160238 · International Biomedical · Jun 2016
BT-400
K142332 · Bio-Med USA · Mar 2015
INFANT PHOTOTHERAPY BILITRON SKY 5006
K131196 · Fanem Lda · Feb 2014
GIRAFFE BLUE SPOT PT LITE
K120820 · Lumitex, Inc. · Jun 2012
K160305 · neoBLUE® LED Phototherapy System
Download PDF FDA Summary Natus Medical Incorpo…