Cleared Traditional

K021531 - RPI REPLACEMENT PHOTOTHERAPY LIGHTS

K021531 is an FDA 510(k) clearance for RPI REPLACEMENT PHOTOTHERAPY LIGHTS, manufactured by Replacement Parts Industries, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K021531 · Replacement Parts Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
21d
Days
Class 2
Risk

K021531 is an FDA 510(k) clearance for the RPI REPLACEMENT PHOTOTHERAPY LIGHTS. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Replacement Parts Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 31, 2002 after a review of 21 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.

View all Replacement Parts Industries, Inc. devices

FDA 510(k) Submission Details - K021531

510(k) Number K021531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date May 31, 2002
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
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 42
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