510(k) · Cleared
ClearedIncuwarmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · FMT Warmer, Infant Radiant
Cleared on Jan 5, 1998 as substantially equivalent to K940951 (Air-Shields, Inc., 1995) and 3 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1995. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jan 5, 1998
- Review
- 266 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K942948 (1995). 5 ancestors in all, the oldest K943360 (1994). 2 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 1 generation backK970074 Stanilet Freestanding/CC Infant/2000C Infant Warmer…Hill-Rom, Inc. · 1997
- This deviceK971366 IncuwarmerHill-Rom, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
- Descendant · 2 generations on · 0 of its ownK053399 Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006
Class I recalls in this family
- K943360 Ohio Care Plus Incubatordirect predicate · 1994
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −1 | K970074 | Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D) | Hill-Rom, Inc. | 1997 | — |
| 0 (this device) | K971366 | Incuwarmer | Hill-Rom, Inc. | 1998 | — |
| +1 | K993051 | Versalet 7700 Care Center, Model # 7700 | Hill-Rom Air-Shields | 2000 | — |
| +2 | K053399 | Versalet 7700 Care Center | Draeger Medical Infant Care, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 1 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940951 | RW Resucitaire Infant Radiant WarmerSummary page 1…I Performance Standards: 21 CFR Part 1020, “Performance Standard for Ionizing Radiation Emitting Products” Predicate (Current) Device: Resuscitaire® Radiant Warmer, K940951 ISOLETTEg® Infant Incubator, K960980 Care Plus Infant Incubator, K943360 Stabilet~ Infant Radiant Warmer, K970074… | 1995 |
| * | K960980 | Isolette Infant IncubatorSummary page 1…t 1020, “Performance Standard for Ionizing Radiation Emitting Products” Predicate (Current) Device: Resuscitaire® Radiant Warmer, K940951 ISOLETTEg® Infant Incubator, K960980 Care Plus Infant Incubator, K943360 Stabilet~ Infant Radiant Warmer, K970074 Device Description The IncuWarmer i… | 1996 |
| * | K943360 | Ohio Care Plus IncubatorSummary page 1…nizing Radiation Emitting Products” Predicate (Current) Device: Resuscitaire® Radiant Warmer, K940951 ISOLETTEg® Infant Incubator, K960980 Care Plus Infant Incubator, K943360 Stabilet~ Infant Radiant Warmer, K970074 Device Description The IncuWarmer is a warming device that combines the… | 1994 |
| * | K970074 | Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D)Summary page 1…dicate (Current) Device: Resuscitaire® Radiant Warmer, K940951 ISOLETTEg® Infant Incubator, K960980 Care Plus Infant Incubator, K943360 Stabilet~ Infant Radiant Warmer, K970074 Device Description The IncuWarmer is a warming device that combines the heating technologies of both incubators… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993051 | Versalet 7700 Care Center, Model # 7700 | 2000 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K943360Ohio Care Plus IncubatorOhmeda Medical · 1994 · Direct predicate · ◆ in the 1994 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K993051 (Hill-Rom Air-Shields, 2000) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K940951.
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMT
103in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMT
4in 2019
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · FMT
359in 2025
MAUDE reports naming product code FMT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 21 |
| 2008 | 0 | — | 1 | 114 |
| 2009 | 1 | — | 2 | 80 |
| 2010 | 1 | — | 0 | 106 |
| 2011 | 1 | — | 0 | 79 |
| 2012 | 4 | 103 | 0 | 54 |
| 2013 | 1 | — | 2 | 55 |
| 2014 | 0 | — | 1 | 79 |
| 2015 | 0 | — | 1 | 56 |
| 2016 | 0 | — | 1 | 56 |
| 2017 | 0 | — | 0 | 46 |
| 2018 | 1 | — | 4 | 79 |
| 2019 | 0 | — | 4 (4) | 1,437 |
| 2020 | 2 | — | 0 | 1,605 |
| 2021 | 1 | — | 0 | 473 |
| 2022 | 1 | — | 0 | 153 |
| 2023 | 1 | — | 0 | 175 |
| 2024 | 0 | — | 0 | 257 |
| 2025 | 1 | — | 0 | 359 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
The IncuWarmer is a mobile,caster mounted, neonatal device which is used to assist in maintaining an infant’s skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in matemity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971366 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971366: Incuwarmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971366
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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