Cleared Traditional

K131196 - INFANT PHOTOTHERAPY BILITRON SKY 5006

K131196 is an FDA 510(k) clearance for INFANT PHOTOTHERAPY BILITRON SKY 5006, manufactured by Fanem Lda. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K131196 · Fanem Lda · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
300d
Days
Class 2
Risk

K131196 is an FDA 510(k) clearance for the INFANT PHOTOTHERAPY BILITRON SKY 5006. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Fanem Lda (Aventura, US). The FDA issued a Cleared decision on February 20, 2014 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 - K131196

510(k) Number K131196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2013
Decision Date February 20, 2014
Days to Decision 300 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
171d slower than avg
Panel avg: 129d · This submission: 300d
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 65
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K131196.
Airborne Phototherapy Light
K160238 · International Biomedical · Jun 2016
neoBLUE® LED Phototherapy System
K160305 · Natus Medical Incorporated · May 2016
BT-400
K142332 · Bio-Med USA · Mar 2015
GIRAFFE BLUE SPOT PT LITE
K120820 · Lumitex, Inc. · Jun 2012
LULLABY LED PHOTTHERAPY SYSTEM
K120168 · Wipro GE Healthcare Private, Ltd. · May 2012
BILI-THERAPY PAD TYPE
K111547 · Atom Medical Corporation · Apr 2012
K131196 · INFANT PHOTOTHERAPY BILITRON SKY 5006
Download PDF FDA Summary Fanem Lda