510(k) · Cleared
ClearedBabypac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical International Ltd., Luton · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Apr 22, 2005 as substantially equivalent to K970158 (Pneupac, Inc., 1998) and 1 other predicate after a 126-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Apr 22, 2005
- Review
- 126 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960515 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK960515 ParapacPneupac, Ltd. · 1996
- 1 generation backK020899 Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DPneupac, Ltd. · 2002
- This deviceK043495 BabypacSmiths Medical International Ltd., Luton · 2005
- Descendant · cites it directly · 0 of its ownK121379 Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv)…Airon Corporation · 2012
Most influential descendants
Showing 1 of 1 · See all- K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960515 | Parapac | Pneupac, Ltd. | 1996 | — |
| −1 | K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D | Pneupac, Ltd. | 2002 | — |
| 0 (this device) | K043495 | Babypac | Smiths Medical International Ltd., Luton | 2005 | — |
| +1 | K121379 | Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit… | Airon Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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.
Planning a device in BTL? 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 |
|---|---|---|---|
| * | K970158 | BabypacSummary page 2…and performance of the babyPAC ventilator, nor affect the mechanically operated alarms protection systems that exist on the predicate babyPAC (K970158) already on the market. The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator… | 1998 |
| * | K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DSummary page 4…icate babyPAC (K970158) to the babyPAC 100. Additionally, comparison testing of the babyPAC 100 with its other predicate counterpart, the paraPAC 'medic' P200 (K020899) was done to show that the ventilator was safe for use in an MRI environment up to 3 Teslas and that the performance of the… | 2002 |
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 |
|---|---|---|---|
| K121379 | Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K121379 (Airon Corporation, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Tesla, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043495 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043495: Babypac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043495
Report an extraction error
Are you the manufacturer?
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