510(k) · Cleared
Recalled · Class I · 2025Drager-Vapor 2000
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 Sep 16, 1997 as substantially equivalent to K940255 (Nutec, Inc., 1994) after a 116-day review. Its family tree reaches back 1 generation to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Sep 16, 1997
- Review
- 116 days
- Class
- Class II
- Product code
- CAD
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940255 (1994). 4 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK940255 Hyperinflation Bag SystemNutec, Inc. · 1994
- This deviceK971923 Drager-Vapor 2000Draeger Medical, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK042276 D-VaporDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK240375 V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK150167 V60 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK060331 Sigma Alpha VaporizerPenlon Limited · 2006
Most influential descendants
Showing 4 of 4 · See all- K042276D-VaporDraeger Medical, Inc. · 2004 · cites it directly2descendants
- K240375V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024 · 2 generations on0descendants
- K150167V60 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly0descendants
- K060331Sigma Alpha VaporizerPenlon Limited · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940255 | Hyperinflation Bag System | Nutec, Inc. | 1994 | — |
| 0 (this device) | K971923 | Drager-Vapor 2000 | Draeger Medical, Inc. | 1997 | — |
| +1 | K042276 | D-Vapor | Draeger Medical, Inc. | 2004 | 1 |
| +2 | K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | — |
| +1 | K150167 | V60 Anesthetic Vaporizer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K060331 | Sigma Alpha Vaporizer | Penlon Limited | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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.
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 CAD device
- #1 K240375 V80 Anesthetic Vaporizer (V80)score 8.9 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K940255 | Hyperinflation Bag SystemSummary page 1…2517967 Manufacturer: Dragerwerk AG Liibeck, Germany Establishment Registration Number: 2517967 Device to which substantial equivalence is claimed: Dréger-Vapor® 19.1 K940255 Device Description: The Dréger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid… | 1994 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2025 | Class I | Z-0933-2026 | Under Investigation by firm | A certain component of affected devices was not delivered within specification and contained impurities. |
| Nov 24, 2025 | Class I | Z-0934-2026 | Under Investigation by firm | A certain component of affected devices was not delivered within specification and contained impurities. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K042276 (Draeger Medical, Inc., 2004) has gone furthest, with 2 descendants 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 | — |
What is it indicated for?
fThe Dréger-Vapor 2000 (Vapor 2000) is a non-heared calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the smglc—agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or scvofluranc. The vaporizer ig not intended for use with desflurane, or for use within an anesthetic breathing 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/K971923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971923: Drager-Vapor 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971923
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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