510(k) · Cleared
ClearedV80 Anesthetic Vaporizer (V80)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Oct 31, 2024 as substantially equivalent to K042276 (Draeger Medical, Inc., 2004) after a 267-day review. Its family tree reaches back 3 generations to 1994. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 31, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940255 (1994). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK940255 Hyperinflation Bag SystemNutec, Inc. · 1994
- 2 generations backK971923 Drager-Vapor 2000Draeger Medical, Inc. · 1997 · Recalled (Class I)
- 1 generation backK042276 D-VaporDraeger Medical, Inc. · 2004 · Recalled
- This deviceK240375 V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024
Class I recalls in this family
- K971923 Drager-Vapor 20002 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940255 | Hyperinflation Bag System | Nutec, Inc. | 1994 | — |
| −2 | K971923 | Drager-Vapor 2000 | Draeger Medical, Inc. | 1997 | Class I |
| −1 | K042276 | D-Vapor | Draeger Medical, Inc. | 2004 | 1 |
| 0 (this device) | K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K042276 | D-VaporSummary page 5…CFR 868.5880, Class II, Anesthetic Vaporizer Regulatory Class: Class II Primary Product Code: CAD 3. PREDICATE DEVICES Primary predicate: • K042276 – D-Vapor Anesthetic Vaporizer, Draeger Medical AG & Co KGaA 510(k) Summary… | 2004 |
| † | K000275 | Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant… | 2000 |
| † | K150167 | V60 Anesthetic Vaporizer | 2015 |
| † | K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K042276.
How does its category compare?
All CAD devicesCAD Vaporizer, Anesthesia, Non-Heated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240375: V80 Anesthetic Vaporizer (V80).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240375
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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