510(k) · Cleared
ClearedPuffin Lite Infant Resuscitation System
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 Jan 18, 2019 as substantially equivalent to K140707 (International Biomedical, 2014) after an 86-day review. Its family tree reaches back 4 generations to 1976. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 18, 2019
- Review
- 86 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K760102 (1976). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- 3 generations backK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- 2 generations backK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- 1 generation backK140707 Lifeborne Infant ResuscitatorInternational Biomedical · 2014
- This deviceK182956 Puffin Lite Infant Resuscitation SystemInternational Biomedical · 2019
Class I recalls in this family
- K070210 Giraffe and Panda T- Piece Resuscitation System2 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| −3 | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| −2 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| −1 | K140707 | Lifeborne Infant Resuscitator | International Biomedical | 2014 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K140707 | Lifeborne Infant ResuscitatorSummary page 4…Regulation: 868.5925 Product Code: BTL Panel: Anesthesiology Predicate Device: LifeBorne Infant Resuscitator, International Biomedi cal, k140707 Device Description: The resuscitation system provides the basic equipment required for pulmonary resuscitation of… | 2014 |
| † | 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?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 43 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Puffin Lite 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/K182956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182956: Puffin Lite Infant Resuscitation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182956
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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