510(k) · Cleared
ClearedDrager-Vapor 19.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Grager · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Jan 27, 1995 after a 274-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 27, 1995
- Review
- 274 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK942055 Drager-Vapor 19.1North American Grager · 1995
- Descendant · cites it directly · 1 of its ownK973051 Drager-Vapor 19.1 W/Plug System S PlusDraeger Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK981773 Drager-Vapor 19.3Draeger Medical, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK981472 Drager-Vapor 19.1 W/Plug System S PlusDraeger Medical, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942055 | Drager-Vapor 19.1 | North American Grager | 1995 | — |
| +1 | K973051 | Drager-Vapor 19.1 W/Plug System S Plus | Draeger Medical, Inc. | 1997 | — |
| +1 | K981773 | Drager-Vapor 19.3 | Draeger Medical, Inc. | 1998 | — |
| +2 | K981472 | Drager-Vapor 19.1 W/Plug System S Plus | Draeger Medical, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
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.
Planning a device in CAD? 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 CAD device
- #1 K240375 V80 Anesthetic Vaporizer (V80)score 8.9 · 3 generations · no Class I recall
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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K973051 (Draeger Medical, Inc., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CAD devicesCAD Vaporizer, Anesthesia, Non-Heated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAD
Too few CAD 510(k)s in any year since 2007 to give a median.
Recalls per year · CAD
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAD
2,678in 2025
MAUDE reports naming product code CAD, 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 | 0 | — | 0 | 30 |
| 2008 | 0 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 39 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 1 | — | 0 | 41 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 1 | — | 5 | 255 |
| 2025 | 0 | — | 2 (2) | 2,678 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K942055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942055: Drager-Vapor 19.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942055
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026