510(k) · Cleared
ClearedLullaby TM Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wipro GE Healthcare Private, Ltd. · FMT Warmer, Infant Radiant
Cleared on Sep 14, 2012 as substantially equivalent to K963058 (Ohmeda Medical, 1996) after a 105-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Sep 14, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963058 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K173516NuBorne Infant WarmerInternational Biomedical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963058 | Infant Warmer System | Ohmeda Medical | 1996 | 3 |
| 0 (this device) | K121625 | Lullaby TM Warmer | Wipro GE Healthcare Private, Ltd. | 2012 | — |
| +1 | K173516 | NuBorne Infant Warmer | International Biomedical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K963058 | Infant Warmer SystemSummary page 1…, General Hospital and Personal use Theraputic Devices Regulation No: 21 CFR 880.5130 Predicate Device(s): Ohmeda OhioR Infant Warmer System (K963058) Device Description: The LullabyTM Warmer is a radiant warmer which provides a micro-… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173516 | NuBorne Infant Warmer | 2018 | 0 |
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. 2012, 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?
Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used to facilitate the newborn's transition to the external environment or to provide a controlled open microenvironment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121625: Lullaby TM Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121625
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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