Cleared Traditional

K070180 - WALLABY 4

K070180 is an FDA 510(k) clearance for WALLABY 4, manufactured by Respironics Inc., Sleep & Home Respiratory Group. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K070180 · Respironics Inc., Sleep & Home Respiratory Group · General Hospital
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Optimized for regulatory review, auditing and printing
May 2007
Decision
119d
Days
Class 2
Risk

K070180 is an FDA 510(k) clearance for the WALLABY 4. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Respironics Inc., Sleep & Home Respiratory Group (Murrysville, US). The FDA issued a Cleared decision on May 18, 2007 after a review of 119 days - within the typical 510(k) review window.

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 Respironics Inc., Sleep & Home Respiratory Group devices

FDA 510(k) Submission Details - K070180

510(k) Number K070180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2007
Decision Date May 18, 2007
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 29
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K070180.
neoBLUE blanket LED Phototherapy System
K182178 · Natus Medical Incorporated · Dec 2018
BiliLux
K172656 · Draeger Medical Systems, Inc. · May 2018
NANOBLUTM 500
K113206 · Draeger Medical Systems, Inc. · Feb 2012
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · Fisher &Paykel Healthcare , Ltd. · Sep 2000
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · Respironics, Inc. · May 1999