510(k) Report

510(k) · Cleared

Cleared

Rpi Replacement Heating Elements

K020966510(k) TraditionalCleared Jun 13, 200280-day reviewClass II21 CFR 880.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Replacement Parts Industries, Inc. · FMT Warmer, Infant Radiant

Cleared on Jun 13, 2002 as substantially equivalent to K790137 (Narco Air-Shields, 1979) and 4 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1979.

Decided
Jun 13, 2002
Review
80 days
Class
Class II
Product code
FMT
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K790137 (1979). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1995: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestorK790137 · Infant Care System · Narco Air-Shields · 1979197519801985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K790137 · Infant Care System · Narco Air-Shields · 19790
  1. Root · 1 generation backK790137 Infant Care SystemNarco Air-Shields · 1979
  2. This deviceK020966 Rpi Replacement Heating ElementsReplacement Parts Industries, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790137Infant Care SystemNarco Air-Shields1979—
0 (this device)K020966Rpi Replacement Heating ElementsReplacement Parts Industries, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199210
199510
200010
FIG. 1 — Lineage of K020966, 1979–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMT device

  1. #1 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K790137Infant Care System
Summary page 1
…n and indications for use to the following devices currently in commercial distribution: RPI Models AIH039 and AM100: Infant Care System, Narco Air-Shields; K790137 RPI Models AIH040 and AM094: Infant Intensive Care System, Free-Standing Infant Warmer, Air-Shields Inc., Hatboro, PA 1…
Narco Air-Shields1979—
*K875270Infant Intensive Care System Vertical Height Adjus
Summary page 1
…System, Narco Air-Shields; K790137 RPI Models AIH040 and AM094: Infant Intensive Care System, Free-Standing Infant Warmer, Air-Shields Inc., Hatboro, PA 19040; K875270 RPI Model AIH097: Resuscitaire Radiant Wanner, Hill-Rom Air-Shields, Hatboro, PA 19040; KO03355 and K940951 RPI Mo…
Air-Shields, Inc.1988—
*K003335Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted…
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”.
Hill-Rom Air-Shields20001
*K940951RW Resucitaire Infant Radiant Warmer
Summary page 1
…t Warmer, Air-Shields Inc., Hatboro, PA 19040; K875270 RPI Model AIH097: Resuscitaire Radiant Wanner, Hill-Rom Air-Shields, Hatboro, PA 19040; KO03355 and K940951 RPI Model AIHO99: Stabilet Infant Radiant Warmer, Hill-Rom, Inc. Batesville, IN 47006; K94904 RPI Model AlH098: St…
Air-Shields, Inc.1995—
Kept off the family treeK094904RPI 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
*K913945Stabilet Infant Radiant Warmer Model 2000C
Summary page 1
…Infant Radiant Warmer, Hill-Rom, Inc. Batesville, IN 47006; K94904 RPI Model AlH098: Stabilet Infant Radiant Warmer, Hill-Rom, Inc., Batesville, TN 47006; K913945 7 IV. DESCRIPTION The RPI Replacement Heating Element…
Hill-Rom, Inc.19921

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 5 ancestors have a recall of any class.

How does its category compare?

All FMT devices

FMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMT

1in 2025

2007: 22009: 12010: 12011: 12012: 42013: 12018: 12020: 22021: 12022: 12023: 12025: 1
2007high 4 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMT

103in 2012

2012: 103 days median
2007high 103 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMT

4in 2019

2008: 12009: 22013: 22014: 12015: 12016: 12018: 42019: 4, 4 Class I2026 (partial year): 2, 2 Class I
2007high 4 (2018) · low 0 (2007)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · FMT

359in 2025

2007: 212008: 1142009: 802010: 1062011: 792012: 542013: 552014: 792015: 562016: 562017: 462018: 792019: 1,4372020: 1,6052021: 4732022: 1532023: 1752024: 2572025: 359
2007high 1,605 (2020) · low 21 (2007)2025

MAUDE reports naming product code FMT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—021
20080—1114
20091—280
20101—0106
20111—079
20124103054
20131—255
20140—179
20150—156
20160—156
20170—046
20181—479
20190—4 (4)1,437
20202—01,605
20211—0473
20221—0153
20231—0175
20240—0257
20251—0359
20260—2 (2)—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Replacement Parts Industries, Inc.

3 FDA decisions under this applicant name. See the company

  • K021531Rpi Replacement Phototherapy LightsReplacement Parts Industries, Inc. · 2002
  • K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc. · 2002

Recent decisions in FMT

The FMT category page

  • K243606Babyroo TN300Draeger Medical Systems, Inc. · 2025
  • K230278Babyroo TN300Draeger Medical Systems, Inc. · 2023
  • K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 20222 Class I recalls
  • K201628Panda iRes Warmer, Giraffe WarmerGE Healthcare · 20211 Class I recall
  • K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor…Deroyal Industries, Inc. · 2020

https://510kreport.com/device/K020966 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020966: Rpi Replacement Heating Elements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020966

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026