# K020966: Rpi Replacement Heating Elements

- Pathway: 510(k) (Traditional)
- Applicant: Replacement Parts Industries, Inc.
- Decided: Jun 13, 2002 after 80 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- 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 K790137 (1979). 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)
- K790137: Infant Care System, Narco Air-Shields (1979) Summary page 1.
- K875270: Infant Intensive Care System Vertical Height Adjus, Air-Shields, Inc. (1988) Summary page 1.
- K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer, Hill-Rom Air-Shields (2000). Our reading of the summary gave K003355, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “RPI Model AIH097: Resuscitaire Radiant Warmer, Hill-Rom Air-Shields”.
- K940951: RW Resucitaire Infant Radiant Warmer, Air-Shields, Inc. (1995) Summary page 1.
- K913945: Stabilet Infant Radiant Warmer Model 2000C, Hill-Rom, Inc. (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K094904: RPI Model AIH099: Stabilet Infant Radiant Warmer, Hill-Rom, Inc.. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer.

Source page: https://510kreport.com/device/K020966
Methodology: https://510kreport.com/methodology