510(k) · Cleared
Recalled · Class I · 2018Modification to: Giraffe and Panda Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMT Warmer, Infant Radiant
Cleared on Apr 16, 2009 as substantially equivalent to K072157 (Ohmeda Medical, 2007) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1997. 5 of the 24 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Apr 16, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 6 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962603 (1997). 22 ancestors in all, the oldest K760102 (1976). 1 later device descends from it, 1 citing it directly. 5 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK033298 SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp. · 2003
- 2 generations backK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- 1 generation backK072157 Modification to Giraffe and Panda Warmers (Giraffe and Panda…Ohmeda Medical · 2007 · Recalled
- This deviceK090697 Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009
- Descendant · cites it directly · 0 of its ownK123309 Giraffe and Panda WarmersOhmeda Medical · 2013 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K033298 | SPO2.Com Oximetry Sensors, Multiple Models | Masimo Corp. | 2003 | — |
| −2 | K070377 | Giraffe and Panda Warmer | Ohmeda Medical | 2007 | Class I |
| −1 | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible… | Ohmeda Medical | 2007 | 1 |
| 0 (this device) | K090697 | Modification to: Giraffe and Panda Warmer | Ohmeda Medical | 2009 | — |
| +1 | K123309 | Giraffe and Panda Warmers | Ohmeda Medical | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
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.
5 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Summary page 1…ormmonlUsual Name: Infant radiant warmers Classification Names: 21 CER 880.5130 Product Code: FMT Predicate Device(s): Giraffe and Panda Warmers (K072 157, K070377) Device Decig tin:The Ohmeda Medical Giraffe and Panda Warmers are devices with a radi… | 2007 |
| * | K070377 | Giraffe and Panda WarmerSummary page 1…al Name: Infant radiant warmers Classification Names: 21 CER 880.5130 Product Code: FMT Predicate Device(s): Giraffe and Panda Warmers (K072 157, K070377) Device Decig tin:The Ohmeda Medical Giraffe and Panda Warmers are devices with a radiant heati… | 2007 |
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 |
|---|---|---|---|
| K123309 | Giraffe and Panda Warmers Class I | 2013 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2018 | Class II | Z-0482-2019 | Process design | Potential electric leakage affecting the user. |
| Sep 25, 2018 | Class II | Z-0481-2019 | Process design | Potential electric leakage affecting the user. |
| Sep 25, 2018 | Class II | Z-0483-2019 | Process design | Potential electric leakage affecting the user. |
| Sep 25, 2018 | Class II | Z-0484-2019 | Process design | Potential electric leakage affecting the user. |
| Nov 18, 2016 | Class II | Z-1508-2017 | Under Investigation by firm | Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where… |
| Oct 1, 2013 | Class I | Z-1072-2014 | Component design/selection | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 13 Class I recalls
- K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 13 Class I recalls
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 7 of the 22 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K123309 (Ohmeda Medical, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072157.
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and…
Read the full statement (121 words)
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
For professional use only, by trained clinicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090697: Modification to: Giraffe and Panda Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090697
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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