510(k) · Cleared
Recalled · Class II · 2016D-Vapor
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 23, 2004 as substantially equivalent to K971923 (Draeger Medical, Inc., 1997) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 23, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- CAD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940255 (1994). 3 ancestors in all. 2 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 · 2 generations backK940255 Hyperinflation Bag SystemNutec, Inc. · 1994
- 1 generation backK971923 Drager-Vapor 2000Draeger Medical, Inc. · 1997 · Recalled (Class I)
- This deviceK042276 D-VaporDraeger Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK240375 V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK060331 Sigma Alpha VaporizerPenlon Limited · 2006
Class I recalls in this family
- K971923 Drager-Vapor 2000direct predicate · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940255 | Hyperinflation Bag System | Nutec, Inc. | 1994 | — |
| −1 | K971923 | Drager-Vapor 2000 | Draeger Medical, Inc. | 1997 | Class I |
| 0 (this device) | K042276 | D-Vapor | Draeger Medical, Inc. | 2004 | — |
| +1 | K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | — |
| +1 | K060331 | Sigma Alpha Vaporizer | Penlon Limited | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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 |
|---|---|---|---|
| * | K971923 | Drager-Vapor 2000Summary page 1…Luebeck, Germany Establishment Registration Number: 9611500 Devices to which substantial equivalence is claimed: Vapor 2000 K971923 Tec 6 Plus K000275 Device Description: The D-Vapor is an electronic calibrated vaporizer designed to enrich… | 1997 |
| * | K000275 | Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant…Summary page 1…, Germany Establishment Registration Number: 9611500 Devices to which substantial equivalence is claimed: Vapor 2000 K971923 Tec 6 Plus K000275 Device Description: The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia de… | 2000 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Apr 21, 2016 | Class II | Z-1812-2016 | Process change control | Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K971923Drager-Vapor 2000Draeger Medical, Inc. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240375 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K971923.
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 D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042276: D-Vapor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042276
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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