510(k) · Cleared
ClearedBabyroo TN300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · FMT Warmer, Infant Radiant
Cleared on Jan 17, 2025 as substantially equivalent to K230278 (Draeger Medical Systems, Inc., 2023) after a 57-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Jan 17, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K892885 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK892885 Resubmitted RD1000 Neopuff Infant ResuscitatorFisher & Paykel Electronics, Ltd. · 1989
- 2 generations backK120642 Resuscitaire with AutobreathDraeger Medical Systems, Inc. · 2012 · Recalled
- 1 generation backK230278 Babyroo TN300Draeger Medical Systems, Inc. · 2023
- This deviceK243606 Babyroo TN300Draeger Medical Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K892885 | Resubmitted RD1000 Neopuff Infant Resuscitator | Fisher & Paykel Electronics, Ltd. | 1989 | — |
| −2 | K120642 | Resuscitaire with Autobreath | Draeger Medical Systems, Inc. | 2012 | 1 |
| −1 | K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023 | — |
| 0 (this device) | K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 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 K230278 Babyroo TN300score 8.7 · 2 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 |
|---|---|---|---|
| * | K230278 | Babyroo TN300Summary page 5…ices The purpose of this premarket notification is the modification of the subject Babyroo TN300 infant warmer device, which was originally cleared under K230278. The modification consists of the activation, for the US market, of existing optional software functionality to f… | 2023 |
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 36 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- 2 of the 5 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. 2025, 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 Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with patients with a body weight up to 10 kg (22 lb).
The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243606: Babyroo TN300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243606
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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