510(k) · Cleared
ClearedLifeborne Infant Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on May 28, 2014 as substantially equivalent to K070210 (Ohmeda Medical, 2007) and 1 other predicate after a 69-day review. Its family tree reaches back 3 generations to 1976. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 28, 2014
- Review
- 69 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K760102 (1976). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- 2 generations backK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- 1 generation backK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- This deviceK140707 Lifeborne Infant ResuscitatorInternational Biomedical · 2014
- Descendant · cites it directly · 0 of its ownK182956 Puffin Lite Infant Resuscitation SystemInternational Biomedical · 2019
Class I recalls in this family
- K070210 Giraffe and Panda T- Piece Resuscitation Systemdirect predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| −2 | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| −1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| 0 (this device) | K140707 | Lifeborne Infant Resuscitator | International Biomedical | 2014 | — |
| +1 | K182956 | Puffin Lite Infant Resuscitation System | International Biomedical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has 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 BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 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 |
|---|---|---|---|
| * | K070210 | Giraffe and Panda T- Piece Resuscitation SystemSummary page 1…ass: H Regulation: 868.5925 Product Code: BTL Panel: Anesthesiology Predicate Device: GE - Giraffe and Panda T-Piece Resuscitation System - k070210 Fisher & Paykel - NeoPuff - k892885 Device Description: The resuscitation system provides the basic equipment req… | 2007 |
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…oduct Code: BTL Panel: Anesthesiology Predicate Device: GE - Giraffe and Panda T-Piece Resuscitation System - k070210 Fisher & Paykel - NeoPuff - k892885 Device Description: The resuscitation system provides the basic equipment required for pulmonary resuscitation of… | 1989 |
| † | K883038 | P/N 9320 Low Flow Air/Oxygen Microblender | 1988 |
| † | K925982 | BMD Air/Oxygen Blender | 1993 |
| † | K093913 | Mercury Medical T-Piece Resuscitator | 2010 |
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 |
|---|---|---|---|
| K182956 | Puffin Lite Infant Resuscitation System | 2019 | 0 |
Has anything in its family been recalled? (1 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.
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K182956 (International Biomedical, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K070210.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140707: Lifeborne Infant Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140707
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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