510(k) · Cleared
Recalled · Class II · 2023Resuscitaire with Autobreath
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 Nov 2, 2012 as substantially equivalent to K003335 (Hill-Rom Air-Shields, 2000) and 2 other predicates after a 245-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2012
- Review
- 245 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K892885 (1989). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK892885 Resubmitted RD1000 Neopuff Infant ResuscitatorFisher & Paykel Electronics, Ltd. · 1989
- This deviceK120642 Resuscitaire with AutobreathDraeger Medical Systems, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK230278 Babyroo TN300Draeger Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243606 Babyroo TN300Draeger Medical Systems, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892885 | Resubmitted RD1000 Neopuff Infant Resuscitator | Fisher & Paykel Electronics, Ltd. | 1989 | — |
| 0 (this device) | K120642 | Resuscitaire with Autobreath | Draeger Medical Systems, Inc. | 2012 | — |
| +1 | K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted…Summary page 1…FMT Class: 11 Legally Marketed Device Identification: Substantial equivalence is claimed to the ResuscitaireS Radiant Warmer K003335, Neopuff Infant Resuscitator K892885, and MVP-10 Infant Ventilator (MVP1O) K89638. Device Description: The modified Resuscitai… | 2000 |
| * | K896381 | MVP-10 Mri Infant VentilatorSummary page 2…Devices Inc. Paykel Systems, Inc. ________ 510(k) Number K003335 K896381 K892885 Regulation Number 880.5130 868.5895 868.5925 8… | 1990 |
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…11 Legally Marketed Device Identification: Substantial equivalence is claimed to the ResuscitaireS Radiant Warmer K003335, Neopuff Infant Resuscitator K892885, and MVP-10 Infant Ventilator (MVP1O) K89638. Device Description: The modified Resuscitaire Radiant Warmer is for newbomn infa… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230278 | Babyroo TN300 | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2023 | Class II | Z-1992-2023 | Device Design | The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. |
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?
The Resuscitaire® Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10kg. It is not intended for long term resuscitation or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120642 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120642: Resuscitaire with Autobreath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120642
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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