510(k) · Cleared
Recalled · Class I · 2026Giraffe and Panda Bag and Mask Resuscitation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Apr 20, 2007 as substantially equivalent to K971243 (Ohmeda Medical, 1997) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1976. 4 of the 11 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Apr 20, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- BTM
- Recalls
- 5 (3 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K760102 (1976). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly. 4 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- 1 generation backK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- This deviceK070247 Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007
- Descendant · cites it directly · 3 of its ownK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK072157 Modification to Giraffe and Panda Warmers (Giraffe and Panda…Ohmeda Medical · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK090697 Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK123309 Giraffe and Panda WarmersOhmeda Medical · 2013 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · cites it directly3descendants
- K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 2007 · 2 generations on2descendants
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 2 generations on1descendant
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| −1 | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| 0 (this device) | K070247 | Giraffe and Panda Bag and Mask Resuscitation System | Ohmeda Medical | 2007 | — |
| +1 | 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 |
| +2 | K090697 | Modification to: Giraffe and Panda Warmer | Ohmeda Medical | 2009 | Class I |
| +2 | K123309 | Giraffe and Panda Warmers | Ohmeda Medical | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2009 | 1 | 1 |
| 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.
4 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 BTM device
- #1 K243861 butterflyBVMscore 9.5 · 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? (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 |
|---|---|---|---|
| * | K971243 | Ohmeda Infant Resuscitation SystemSummary page 1…Bag and Mask Resuscitation System is substantially equivalent to the following predicate devices: Ohmeda Medical Infant Resuscitation System K971243 AirShields Resuscitaire K003335 Atom InfaWarmer V505… | 1997 |
| * | K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted…Summary page 1…llowing predicate devices: Ohmeda Medical Infant Resuscitation System K971243 AirShields Resuscitaire K003335 Atom InfaWarmer V505 K002355 Intended Use Statement The Bag and Mask Resuscitat… | 2000 |
| * | K002355 | Atom Infa Warmer V-505Summary page 1…K971243 AirShields Resuscitaire K003335 Atom InfaWarmer V505 K002355 Intended Use Statement The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscit… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070377 | Giraffe and Panda Warmer Class I | 2007 | 3 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2026 | Class I | Z-2357-2026 | 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… |
| Dec 12, 2013 | Class II | Z-0915-2014 | 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-0914-2014 | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. |
| Oct 1, 2013 | Class I | Z-1071-2014 | Component design/selection | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
| Oct 15, 2012 | Class I | Z-0749-2013 | Employee error | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 21.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K070377 (Ohmeda Medical, 2007) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K971243.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, 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 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Bag and Mask Resuscitation System provides 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. These are clinical practices that represent the established standard of care.* Resuscitation may be required whenever an infant fails to establish effective, adequate breathing…
Read the full statement (112 words)
The Bag and Mask Resuscitation System provides 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. These are clinical practices that represent the established standard of care.*
Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.
For professional use only, by trained clinicians.
* As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5th Edition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070247: Giraffe and Panda Bag and Mask Resuscitation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070247
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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