510(k) · Cleared
ClearedV60 Anesthetic Vaporizer
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 Jun 30, 2015 as substantially equivalent to K971923 (Draeger Medical, Inc., 1997) after a 155-day review. Its family tree reaches back 2 generations to 1994. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 30, 2015
- Review
- 155 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940255 (1994). No later device cites it as a predicate yet. 1 of the 3 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 deviceK150167 V60 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Class I recalls in this family
- K971923 Drager-Vapor 2000direct predicate · 1997
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K971923 | Drager-Vapor 2000Summary page 5…FAX: (86) - 755-2658 2680 EMAIL: [email protected] 4. Legally Marketed Predicate Devices Device Name: DRAGER-VAPOR 2000 K-number: K971923 Product Code: CAD Intended Use: The Vapor 2000 is intended for vaporization and delivery of a controlled… | 1997 |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 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. 2015, 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?
V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system.
The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150167: V60 Anesthetic Vaporizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150167
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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