Cleared Traditional

K103589 - NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

K103589 is an FDA 510(k) clearance for NEOBLUE BLANKET 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 157-day FDA review.

K103589 · Natus Medical Incorporated · General Hospital
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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.

View all Natus Medical Incorporated devices

FDA 510(k) Submission Details - K103589

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 129d · This submission: 157d
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 40
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K103589.
NANOBLUTM 500
K113206 · Draeger Medical Systems, Inc. · Feb 2012
BRIGHT EMBRACE MODEL SBL60
K110550 · Physician Engineered Products, Inc. · Feb 2012
MEDILED MINI
K103735 · Medix I.C.S.A. · Aug 2011
BILI-THERAPY SPOT TYPE
K103828 · Atom Medical Corporation · Mar 2011
WALLABY 4
K070180 · Respironics Inc., Sleep & Home Respiratory Group · May 2007
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001