NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM— 510(k) K103589

Clearance details

Applicant

Natus Medical Incorporated

Product code

Code LBI

Device class

Class 2

Regulation

21 CFR 880.5700

Advisory panel

General Hospital

Date received

2010-12-07

Decision date

2011-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Seattle, WA, US

• K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
• K243372 — BiliWrap2025-05-29
• K210289 — Infant Phototherapy Equipment2021-05-28
• K200031 — Neonatal Phototherapy System2020-10-05
• K190899 — bili-hut2019-09-05

• K182178 — neoBLUE blanket LED Phototherapy System2018-12-13
• K182263 — RetCam 3; RetCam Shuttle; RetCam Portable2018-09-07
• K160745 — neoBLUE compact LED Phototherapy System2016-12-12
• K160305 — neoBLUE® LED Phototherapy System2016-05-27
• K143440 — Natus Quantum2015-04-20

• Z-0770-2017 — Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUSClass II·Terminated·Natus Medical Incorporated·20161028
• Z-0769-2017 — Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected. 2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life. Affected Part Numbers and Description: 006244 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUSClass II·Terminated·Natus Medical Incorporated·20160916
• Z-1412-2015 — Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUSClass II·Terminated·Natus Medical Incorporated·20150316

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103589.