510(k) · Cleared
ClearedDrager-Vapor 19.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical, Inc. · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Jul 6, 1998 as substantially equivalent to K771899 (Draeger Medical, Inc., 1977) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Jul 6, 1998
- Review
- 47 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K771899 (1977). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK771899 VAPOR 19Draeger Medical, Inc. · 1977
- This deviceK981773 Drager-Vapor 19.3Draeger Medical, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771899 | VAPOR 19 | Draeger Medical, Inc. | 1977 | — |
| 0 (this device) | K981773 | Drager-Vapor 19.3 | Draeger Medical, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 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? (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 |
|---|---|---|---|
| * | K771899 | VAPOR 19Summary page 1…ment Registration No.: 2517967 Manufacturer: Driger Medizintechnik GmbH ' Liibeck, Germany Establishment Registration No.: 9611500 Predicate Devices: Driger-Vapor® 19 (K771899) Driger-Vapor® 19 for Sevoflurane (K942055) Device Description The Drager-Vapor 19.3 (Vapor 19.3) is a concentration calibrate… | 1977 |
| * | K942055 | Drager-Vapor 19.1Summary page 1…Driger Medizintechnik GmbH ' Liibeck, Germany Establishment Registration No.: 9611500 Predicate Devices: Driger-Vapor® 19 (K771899) Driger-Vapor® 19 for Sevoflurane (K942055) Device Description The Drager-Vapor 19.3 (Vapor 19.3) is a concentration calibrated non-heated vaporizer for vaporizing liquid… | 1995 |
| † | K981472 | Drager-Vapor 19.1 W/Plug System S Plus | 1998 |
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?
- None of the 2 ancestors has a recall.
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 | — |
What is it indicated for?
The Driger-Vapor 19.3 is a non-heated calibrated vaporizer to enrich the fresh gas flow of an anesthesia delivery system with a controlled anesthetic agent vapor. The Vapor 19.3 is indicated for use with enflurane, halothane, isoflurane, and sevoflurane. The Vapor 19.3 is not indicated for use with desflurane or in the breathing circuit of an anesthesia delivery system. Federal law restricts this device to sale by or on the order of a physician.
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/K981773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981773: Drager-Vapor 19.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981773
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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