510(k) · Cleared
ClearedParapac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pneupac, Ltd. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Oct 10, 1996 after a 248-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 10, 1996
- Review
- 248 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK960515 ParapacPneupac, Ltd. · 1996
- Descendant · cites it directly · 3 of its ownK020899 Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DPneupac, Ltd. · 2002
- Descendant · 2 generations on · 1 of its ownK043495 BabypacSmiths Medical International Ltd., Luton · 2005
- Descendant · 2 generations on · 0 of its ownK123957 Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK121379 Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv)…Airon Corporation · 2012
Class I recalls in this family
- K123957 Pneupac Parapac Plus2 generations on · 2013
Most influential descendants
Showing 4 of 4 · See all- K020899Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DPneupac, Ltd. · 2002 · cites it directly3descendants
- K043495BabypacSmiths Medical International Ltd., Luton · 2005 · 2 generations on1descendant
- K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · 2 generations on0descendants
- K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960515 | Parapac | Pneupac, Ltd. | 1996 | — |
| +1 | K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D | Pneupac, Ltd. | 2002 | — |
| +2 | K043495 | Babypac | Smiths Medical International Ltd., Luton | 2005 | — |
| +2 | K123957 | Pneupac Parapac Plus | Smiths Medical International, Ltd. | 2013 | Class I |
| +3 | K121379 | Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit… | Airon Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D | 2002 | 3 |
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.
- K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
- Of its descendants, K020899 (Pneupac, Ltd., 2002) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K960515 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960515: Parapac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960515
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026