510(k) · Cleared
ClearedBabyleo TN500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draegerwerk AG & CO Kgaa · FMZ Incubator, Neonatal
Cleared on Jun 23, 2017 as substantially equivalent to K010222 (Ohmeda Medical, 2001) after a 259-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jun 23, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010222 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010222 Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2001 · Recalled
- This deviceK162821 Babyleo TN500Draegerwerk AG & CO Kgaa · 2017
- Descendant · cites it directly · 1 of its ownK182859 Babyleo TN500Dragerwerk AG & CO Kgaa · 2019
- Descendant · 2 generations on · 0 of its ownK251619 Babyleo TN500Drägerwerk AG & Co. KGaA · 2026
- Descendant · cites it directly · 0 of its ownK173516 NuBorne Infant WarmerInternational Biomedical · 2018
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 | K010222 | Ohmeda Medical Giraffe Incubator | Ohmeda Medical | 2001 | 3 |
| 0 (this device) | K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | 2017 | — |
| +1 | K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | 2019 | — |
| +2 | K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2026 | — |
| +1 | K173516 | NuBorne Infant Warmer | International Biomedical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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 FMZ? 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 FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 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 |
|---|---|---|---|
| * | K010222 | Ohmeda Medical Giraffe IncubatorSummary page 5…N500 K162821 Traditional 510(k) Babyleo TN500 Legally Marketed Devices to which Substantial Equivalence is claimed: Legally Marketed Predicate Device: K010222, Ohmeda Medical Giraffe Incubator Reference Devices: K003067, CALEO K971198, Babytherm 8004/8010 Device Description: The devic… | 2001 |
| † | K003067 | CALEO | 2000 |
| † | K971198 | Babytherm 8004 Babytherm 8010 | 1997 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, 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 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 Ibs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care…
Read the full statement (155 words)
Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 Ibs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)
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/K162821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162821: Babyleo TN500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162821
Report an extraction error
Are you the manufacturer?
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