510(k) · Cleared
ClearedComppac Ventilator Models 200 & PS11 Power Supply/Charger
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 Jul 17, 2003 as substantially equivalent to K905697 (Impact Instrumentation, Inc., 1990) after a 407-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Jul 17, 2003
- Review
- 407 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905697 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK905697 Powered Ventilator, Lever I/II, Battlefield UseImpact Instrumentation, Inc. · 1990
- This deviceK021841 Comppac Ventilator Models 200 & PS11 Power Supply/ChargerPneupac, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK040090 Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power…Pneupac, Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040090Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)Pneupac, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905697 | Powered Ventilator, Lever I/II, Battlefield Use | Impact Instrumentation, Inc. | 1990 | — |
| 0 (this device) | K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/Charger | Pneupac, Ltd. | 2003 | — |
| +1 | K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains) | Pneupac, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K905697 | Powered Ventilator, Lever I/II, Battlefield UseSummary page 1…Predicate Device: Univent Eagle Battery Powered Emergency Ventilator (K905697) New Device Description: The compPAC COM 200 ventilator is primarily gas powered and is housed in an easily carried, chemically… | 1990 |
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 |
|---|---|---|---|
| K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains) | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K040090 (Pneupac, Ltd., 2004) 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 Pneupac compPAC 200 ventilator is a self contained portable gas powered automatic ventilator intended to provide emergency ventilation, in a battlefield environment only, to adult and pediatric patients greater than 20 kg. The compPAC 200 is suitable for emergency and transport use in situations where conventional portable ventilators are not suitable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021841: Comppac Ventilator Models 200 & PS11 Power Supply/Charger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021841
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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