510(k) · Cleared
ClearedGav - General Anaesthetic Vaporizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Anaesthetic Services Limited · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Aug 23, 2005 as substantially equivalent to K892057 (Ohmeda Medical, 1989) after a 62-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 23, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K892057 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK892057 Ohmeda Tec 5 Continuous Flow VaporizerOhmeda Medical · 1989
- This deviceK051666 Gav - General Anaesthetic VaporizerGeneral Anaesthetic Services Limited · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892057 | Ohmeda Tec 5 Continuous Flow Vaporizer | Ohmeda Medical | 1989 | — |
| 0 (this device) | K051666 | Gav - General Anaesthetic Vaporizer | General Anaesthetic Services Limited | 2005 | — |
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? (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 |
|---|---|---|---|
| * | K892057 | Ohmeda Tec 5 Continuous Flow VaporizerSummary page 1…Product Code: CAD Regulation Number: 21 CFR 868.5880 510(k) Number: K892057 510O(k) Summary - Rev. 1 Page 1 of 3… | 1989 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K892057.
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 GAV General Anesthetic Vaporizer is a concentration-calibrated device
intended to deliver specific anesthetic agents into the fresh gas supply of
an anesthesia workstation or anesthesia gas machine. The volatile agents
intended to be used with this device are: Isoflurane, Sevoflurane and
Halothane.
US Federal law restricts this device for sale by or on the order of a licensed
physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051666: Gav - General Anaesthetic Vaporizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051666
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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