510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K131196Substantially Equivalent

Infant Phototherapy Bilitron Sky 5006

Fanem Lda, Aventura FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131196 is the FDA 510(k) clearance record for INFANT PHOTOTHERAPY BILITRON SKY 5006, a class II device, cleared for Fanem Lda on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list one 510(k) clearance for Fanem Lda. As of , FDA records show no recalls naming K131196.

Clearance record

Decision date
Received
(300 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Fanem Lda 18851 NE 29th Ave., Aventura FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBI

Trailing 12 months
1 clearance under product code LBI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260