510(k) · Cleared
ClearedComppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)
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 May 27, 2004 as substantially equivalent to K021841 (Pneupac, Ltd., 2003) after a 132-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- May 27, 2004
- Review
- 132 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905697 (1990). No later device cites it as a predicate yet.
- Root · 2 generations backK905697 Powered Ventilator, Lever I/II, Battlefield UseImpact Instrumentation, Inc. · 1990
- 1 generation backK021841 Comppac Ventilator Models 200 & PS11 Power Supply/ChargerPneupac, Ltd. · 2003
- This deviceK040090 Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power…Pneupac, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905697 | Powered Ventilator, Lever I/II, Battlefield Use | Impact Instrumentation, Inc. | 1990 | — |
| −1 | K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/Charger | Pneupac, Ltd. | 2003 | — |
| 0 (this device) | K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains) | Pneupac, Ltd. | 2004 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/Charger | 2003 |
| Kept off the family tree | K020069 | FDA’s K020069 is Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 2 ancestors has a 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.
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 Pneupac compPAC 200HD ventilator is a self contained portable gas powered automatic gas ventilator intended to provide ventilation to patients who have respiratory ditress or insufficiency. The comPAC 200HD is suitable for emergency and transport use for adult and paediatric patients greater than 20Kg in situations where convential portable ventilators may not be suitable
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/K040090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040090: Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040090
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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