# K021531: Rpi Replacement Phototherapy Lights

- Pathway: 510(k) (Traditional)
- Applicant: Replacement Parts Industries, Inc.
- Decided: May 31, 2002 after 21 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K840454 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875270: Infant Intensive Care System Vertical Height Adjus, Air-Shields, Inc. (1988) Summary page 1.
- K840454: Phototherapy Unit 7850 Neonatal Photo, Air-Shields, Inc. (1984) Summary page 1.
- K971256: Duo-Lite Phototherapy System, Air-Shields, Inc. (1997) Summary page 1.
- K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer, Hill-Rom Air-Shields (2000) Summary page 1.
- K940951: RW Resucitaire Infant Radiant Warmer, Air-Shields, Inc. (1995) Summary page 1.

## Indications for use
RPI replacement phototherapy bulbs are designed to be used as replacement light bulbs for use with various phototherapy units and infant radiant warmers.

Source page: https://510kreport.com/device/K021531
Methodology: https://510kreport.com/methodology