510(k) · Cleared
ClearedDatex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)
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 Jun 26, 2003 as substantially equivalent to K942091 (Ohmeda Medical, 1995) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Jun 26, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K892057 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK892057 Ohmeda Tec 5 Continuous Flow VaporizerOhmeda Medical · 1989
- 1 generation backK012924 Datex-Ohmeda Tec 7 Anesthesia VaporizerDatex-Ohmeda, Inc. · 2002 · Recalled
- This deviceK031027 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 1 of 1 · See all- K172702Tec 820, Tec 850Datex-Ohmeda, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892057 | Ohmeda Tec 5 Continuous Flow Vaporizer | Ohmeda Medical | 1989 | — |
| −1 | K012924 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer | Datex-Ohmeda, Inc. | 2002 | 1 |
| 0 (this device) | 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 |
|---|---|---|
| 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? (3)
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…c 5 Anesthesia Vaporizers (isoflurane, halothane, sevoflurane, enflurane), which were the subject of cleared 5 10(k) premarket notifications K012924, K942091 and K 80205 7. The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of… | 1995 |
| * | K892057 | Ohmeda Tec 5 Continuous Flow VaporizerSummary page 2…1 Device Panel: Anesthesiology Predicate Devices Datex-Ohmeda Tec 5 Anesthesia Vaporizer 510(k)s K942091 and K892057 (isoflurane, halothane, sevoflurane, enflurane) Datex-Ohmeda Tec 7 Anesthesia Vaporizer 5 1O(k) KO 12924… | 1989 |
| * | K012924 | Datex-Ohmeda Tec 7 Anesthesia VaporizerSummary page 1…hrneda Tec 5 Anesthesia Vaporizers (isoflurane, halothane, sevoflurane, enflurane), which were the subject of cleared 5 10(k) premarket notifications K012924, K942091 and K 80205 7. The Datex-Ohmeda Tec 7 vaporizer is designed for the metered del… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172702 | Tec 820, Tec 850 | 2018 | 0 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K172702 (Datex-Ohmeda, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K942091.
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-Ohnieda 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, sevoflurane and enflurane 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 as stated in the FDA summary.
https://510kreport.com/device/K031027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031027: Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031027
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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