Cleared Traditional

K071828 - LULLABY

K071828 is an FDA 510(k) clearance for LULLABY, manufactured by Ge Healthcare Clinical Systems. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K071828 · Ge Healthcare Clinical Systems · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
34d
Days
Class 2
Risk

K071828 is an FDA 510(k) clearance for the LULLABY. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Ge Healthcare Clinical Systems (Laurel, US). The FDA issued a Cleared decision on August 6, 2007 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K071828

510(k) Number K071828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date August 06, 2007
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 70
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K071828.
BILI BLUE F20T12/BBY AND F40T12/BBY
K090192 · Interlectric Corp. · Apr 2009
MEDILED PHOTOTHERAPY LAMP
K083179 · Medix I.C.S.A. · Feb 2009
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
K072097 · Medical Select, Inc. · Oct 2007
WALLABY 4
K070180 · Respironics Inc., Sleep & Home Respiratory Group · May 2007
BILISOFT PHOTOTHERAPY SYSTEM
K053568 · Lumitex, Inc. · Apr 2006
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
K051869 · Natus Medical, Inc. · Oct 2005
K071828 · LULLABY
Download PDF FDA Summary Ge Healthcare Clinica…