Cleared Special

WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 (K991627) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K991627 · Respironics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
6d
Days
Class 2
Risk

K991627 is an FDA 510(k) clearance for the WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 6 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

Submission Details

510(k) Number K991627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1999
Decision Date May 17, 1999
Days to Decision 6 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 129d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K991627.
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