510(k) · Cleared
ClearedNuBorne Infant Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical · FMT Warmer, Infant Radiant
Cleared on Aug 17, 2018 as substantially equivalent to K121625 (Wipro GE Healthcare Private, Ltd., 2012) and 1 other predicate after a 276-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 17, 2018
- Review
- 276 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963058 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963058 | Infant Warmer System | Ohmeda Medical | 1996 | 3 |
| −1 | K121625 | Lullaby TM Warmer | Wipro GE Healthcare Private, Ltd. | 2012 | — |
| 0 (this device) | K173516 | NuBorne Infant Warmer | International Biomedical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K121625 | Lullaby TM WarmerSummary page 4…Regulatory Class: II Regulation: 880.5130 Product Code: FMT Panel: General Hospital Predicate Device: GE Medical – Lullaby Warmer – k121625 (Primary Predicate) Drager Medical Systems – Babyleo TN500 – k162821 (Supplemental Predicate) Device Description:… | 2012 |
| * | K162821 | Babyleo TN500Summary page 4…: FMT Panel: General Hospital Predicate Device: GE Medical – Lullaby Warmer – k121625 (Primary Predicate) Drager Medical Systems – Babyleo TN500 – k162821 (Supplemental Predicate) Device Description: The NuBorne Infant Warmer is an open care environment used for providing co… | 2017 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 16.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother’s womb to the external environment. The device is intended to be used in a Labor & Delivery environment for warming the infants immediately after birth, or in a Neonatal Intensive Care Unit for providing…
Read the full statement (154 words)
The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother’s womb to the external environment.
The device is intended to be used in a Labor & Delivery environment for warming the infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration thermoregulation therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/long duration warming therapy.
The device allows access to the infants for various procedures, tilting of the mattress, weighing the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173516: NuBorne Infant Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173516
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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