510(k) · Cleared
Recalled · Class I · 2026Giraffe and Panda Warmers
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 Feb 5, 2013 as substantially equivalent to K122267 (Ohmeda Medical, A Division of Datex-Ohmeda, Inc., 2012) and 4 other predicates after a 104-day review. Its family tree reaches back 8 generations to 1997. 7 of the 26 devices in its family, counting itself, have a Class I recall. It has been recalled 13 times, including 3 Class I recalls.
- Decided
- Feb 5, 2013
- Review
- 104 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 13 (3 Class I)
- Predicates
- 5
Its longest line of descent runs back 8 generations to K962603 (1997). 25 ancestors in all, the oldest K760102 (1976). No later device cites it as a predicate yet. 7 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK033298 SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp. · 2003
- 3 generations backK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- 2 generations backK072157 Modification to Giraffe and Panda Warmers (Giraffe and Panda…Ohmeda Medical · 2007 · Recalled
- 1 generation backK090697 Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · Recalled (Class I)
- This deviceK123309 Giraffe and Panda WarmersOhmeda Medical · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K033298 | SPO2.Com Oximetry Sensors, Multiple Models | Masimo Corp. | 2003 | — |
| −3 | K070377 | Giraffe and Panda Warmer | Ohmeda Medical | 2007 | Class I |
| −2 | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible… | Ohmeda Medical | 2007 | 1 |
| −1 | K090697 | Modification to: Giraffe and Panda Warmer | Ohmeda Medical | 2009 | Class I |
| 0 (this device) | K123309 | Giraffe and Panda Warmers | Ohmeda Medical | 2013 | — |
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 |
| 2010 | 1 | 1 |
| 2012 | 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.
7 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? (5)
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 |
|---|---|---|---|
| * | K122267 | Giraffe and Panda WarmersSummary page 1…Infant Warmer Classification Names: Warmer, Infant Radiant Product Code: FMT 880.5130 Predicate Device(s): Giraffe and Panda Warmers; K 122267, K 10 1804, K(090697, K(072157, K070377 Device Description: The Giraffe and Panda Warme… | 2012 |
| * | K101804 | Giraffe and Panda WarmersSummary page 1…mer Classification Names: Warmer, Infant Radiant Product Code: FMT 880.5130 Predicate Device(s): Giraffe and Panda Warmers; K 122267, K 10 1804, K(090697, K(072157, K070377 Device Description: The Giraffe and Panda Warmers are devi… | 2010 |
| * | K090697 | Modification to: Giraffe and Panda WarmerSummary page 2…w configurations provide heat to a patient using the same patient temperature control algorithm previously cleared per 5 10(k) K090697. The Maximum heater output has been reduced to support use of tall bassinets. The pre… | 2009 |
| * | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Summary page 1…ant Product Code: FMT 880.5130 Predicate Device(s): Giraffe and Panda Warmers; K 122267, K 10 1804, K(090697, K(072157, K070377 Device Description: The Giraffe and Panda Warmers are devices with a radiant heating… | 2007 |
| * | K070377 | Giraffe and Panda WarmerSummary page 1…Product Code: FMT 880.5130 Predicate Device(s): Giraffe and Panda Warmers; K 122267, K 10 1804, K(090697, K(072157, K070377 Device Description: The Giraffe and Panda Warmers are devices with a radiant heating so… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2026 | Class I | Z-2359-2026 | Process control | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or… |
| Mar 15, 2019 | Class I | Z-1847-2019 | Device Design | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle. |
| Mar 15, 2019 | Class I | Z-1846-2019 | Device Design | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle. |
| 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. |
| Apr 2, 2014 | Class II | Z-1547-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Apr 2, 2014 | Class II | Z-1550-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Apr 2, 2014 | Class II | Z-1549-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Apr 2, 2014 | Class II | Z-1548-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Dec 12, 2013 | Class II | Z-0913-2014 | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. |
| Dec 12, 2013 | Class II | Z-0912-2014 | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. |
The 5 latest of 13 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.
- K122267Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K101804Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 25 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K122267.
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SPO 2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp0z) and…
Read the full statement (115 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 SPO 2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp0z) and pulse rate (measured by an SPOZ 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123309: Giraffe and Panda Warmers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123309
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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