510(k) · Cleared
Recalled · Class II · 2017Datex-Ohmeda Tec 7 Anesthesia Vaporizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Jan 30, 2002 as substantially equivalent to K942091 (Ohmeda Medical, 1995) and 1 other predicate after a 152-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 30, 2002
- Review
- 152 days
- Class
- Class II
- Product code
- CAD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892057 (1989). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK892057 Ohmeda Tec 5 Continuous Flow VaporizerOhmeda Medical · 1989
- This deviceK012924 Datex-Ohmeda Tec 7 Anesthesia VaporizerDatex-Ohmeda, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK031027 Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)Datex-Ohmeda, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK172702 Tec 820, Tec 850Datex-Ohmeda, Inc. · 2018 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K892057 | Ohmeda Tec 5 Continuous Flow Vaporizer | Ohmeda Medical | 1989 | — |
| 0 (this device) | K012924 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer | Datex-Ohmeda, Inc. | 2002 | — |
| +1 | K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane) | Datex-Ohmeda, Inc. | 2003 | — |
| +1 | K172702 | Tec 820, Tec 850 | Datex-Ohmeda, Inc. | 2018 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2018 | 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.
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? (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 |
|---|---|---|---|
| * | K942091 | Ohmeda Tec 5 Vaporizer for Use with SevofluraneSummary page 1…Datex-Ohmeda Tec 7 Anesthesia Vaporizer is substantially equivalent to the currently marketed Datex-Ohmeda Tec 5 anesthesia Vaporizer, which was the subject of 510(k)s K942091 and K892057. The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for… | 1995 |
| * | K892057 | Ohmeda Tec 5 Continuous Flow VaporizerSummary page 1…a Tec 7 Anesthesia Vaporizer is substantially equivalent to the currently marketed Datex-Ohmeda Tec 5 anesthesia Vaporizer, which was the subject of 510(k)s K942091 and K892057. The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in conti… | 1989 |
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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2017 | Class II | Z-1198-2018 | Process control | Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane and sevoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
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/K012924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012924: Datex-Ohmeda Tec 7 Anesthesia Vaporizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012924
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026