510(k) · Cleared
ClearedOhmeda Infant 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 Dec 2, 1997 as substantially equivalent to K760102 (Ohio Medical Products, 1976) and 2 other predicates after a 243-day review. Its family tree reaches back 1 generation to 1976. 6 of the 16 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Dec 2, 1997
- Review
- 243 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K760102 (1976). 3 ancestors in all. 12 later devices descend from it, 2 citing it directly. 6 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- This deviceK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- Descendant · cites it directly · 10 of its ownK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK070247 Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · 3 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 ownK140707 Lifeborne Infant ResuscitatorInternational Biomedical · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · cites it directly10descendants
- K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · cites it directly4descendants
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on3descendants
- K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 2007 · 3 generations on2descendants
- K140707Lifeborne Infant ResuscitatorInternational Biomedical · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| 0 (this device) | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| +1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| +1 | K070247 | Giraffe and Panda Bag and Mask Resuscitation System | Ohmeda Medical | 2007 | Class I |
| +2 | K070377 | Giraffe and Panda Warmer | Ohmeda Medical | 2007 | Class I |
| +3 | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible… | Ohmeda Medical | 2007 | 1 |
| +2 | K140707 | Lifeborne Infant Resuscitator | International Biomedical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 3 |
| 2009 | 1 | 1 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
6 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? (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 |
|---|---|---|---|
| * | K760102 | Flowmeter, P.C., Redesigned VersionSummary page 1…stem 510(k) Summary DEC - 2 jog7 i oo Informat The IRS is a combination of the following stand-alone medical devices: Ohio Pressure Compensated Flowmeter - 510(k) No. K760102 Ohio Continuous Suction Regulator (wall vacuum powered) - 510(k) No. K883229 Ohio Continuous Suction Regulator (venturi powered)… | 1976 |
| * | K883229 | Ohmeda Continuous Suction RegulatorSummary page 1…he following stand-alone medical devices: Ohio Pressure Compensated Flowmeter - 510(k) No. K760102 Ohio Continuous Suction Regulator (wall vacuum powered) - 510(k) No. K883229 Ohio Continuous Suction Regulator (venturi powered) - Substantially equivalent to the wall vacuum powered configuration Ohmeda O… | 1988 |
| * | K853905 | Ohmeda Oxygen BlenderSummary page 1…) No. K883229 Ohio Continuous Suction Regulator (venturi powered) - Substantially equivalent to the wall vacuum powered configuration Ohmeda Oxygen Blender - 510(k) No. K853905 Airway Manometer - Substantially equivalent to the Airway Manometer included in the resuscitation section of the Air Shields Res… | 1985 |
| * | — | Air Shields Resuscitaire™ (resuscitation section / Radiant Warmer) Named without a submission number | |
| * | — | Hill Rom Stabilet 2000C Infant Warmer (resuscitation section) Named without a submission number |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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.
- K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K070210 (Ohmeda Medical, 2007) has gone furthest, with 10 descendants of its own.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation during infancy. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP). Resuscitation may be required whenever an…
Read the full statement (321 words)
The Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation during infancy. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP).
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.
The Infant Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for routine clearance of the trachea and nasal passages; an oxygen flowmeter to deliver 100% oxygen to the infant requiring such therapy; and an airway pressure manometer with an adjustable pressure relief valve (12-55 cm H20). The airway pressure manometer may be attached to a resuscitation_bag (not included) and is used to measure the pressure being delivered to the infant in order to facilitate adequate pressurization of the lungs. An adjustable pressure relief valve is a safety feature which helps prevent the user from over-inflating the infant’s lungs, which could result in rupture of the alveoli. The valve may be adjusted to release excess gas at a user selected pressure point. The ability to adjust the pressure relief valve facilitates optimal oxygen delivery as-ling compliance changes dynamically after birth during the transition to extrauterine life. The operative range (12-55 cm H20) of this feature meets the recommendations by the AHA and AAP. The Infant Resuscitation System is outfitted with unregulated air and oxygen outlet connection which may be attached to an optional gas blender for the purposes of delivering air and oxygen mixes in the user selected percentages. The Resuscitation System may be equipped with optional hoses to connect the system to wall or cylinder outlets and/or yoke assemblies.
The Infant Resuscitation System does not include the resuscitation bag for manual ventilation.
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/K971243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971243: Ohmeda Infant 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/K971243
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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