510(k) · Cleared
ClearedStanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D)
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 Apr 3, 1997 as substantially equivalent to K942948 (Stryker Corp., 1995) after an 85-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Apr 3, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942948 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942948 Stryker Powered StretcherStryker Corp. · 1995
- This deviceK970074 Stanilet Freestanding/CC Infant/2000C Infant Warmer…Hill-Rom, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK971366 IncuwarmerHill-Rom, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
- Descendant · 3 generations on · 0 of its ownK053399 Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| 0 (this device) | K970074 | Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D) | Hill-Rom, Inc. | 1997 | — |
| +1 | K971366 | Incuwarmer | Hill-Rom, Inc. | 1998 | — |
| +2 | K993051 | Versalet 7700 Care Center, Model # 7700 | Hill-Rom Air-Shields | 2000 | — |
| +3 | K053399 | Versalet 7700 Care Center | Draeger Medical Infant Care, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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.
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 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? (1)
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 |
|---|---|---|---|
| * | K942948 | Stryker Powered StretcherSummary page 1…al Hospital and Personal Use Device, 21 CFR 880.5130 , Infant Radiant Warmer, 80FMT, Class III Predicate (Current) Device: Hill-Rom " Stabilet~" Infant Radiant Warmer, K942948 Device Description The Hill-Rom Stabilet~ is a device consisting of an infrared heating element positioned over an infant to ma… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971366 | Incuwarmer | 1998 | 2 |
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?
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 Stabilet~ Infant Radiant Warmer maintains the infant’s body temperature at a level determined by the caregiver through the use of an infrared radiant heating element and is designed to be used in those areas of the healthcare facility that provide neonatal and infant care.
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/K970074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970074: Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970074
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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