Cleared Traditional

K040853 - PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101

K040853 is an FDA 510(k) clearance for PHOENIX PHOTOTHERAPY UNIT CFL, manufactured by International Hospital Supply Co.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K040853 · International Hospital Supply Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
81d
Days
Class 2
Risk

K040853 is an FDA 510(k) clearance for the PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by International Hospital Supply Co. (Amsterdam, NL). The FDA issued a Cleared decision on June 21, 2004 after a review of 81 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 - K040853

510(k) Number K040853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2004
Decision Date June 21, 2004
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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
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K040853 · PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
Download PDF FDA Summary International Hospita…