510(k) · Cleared
ClearedOhmeda Tec 5 Continuous Flow Vaporizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Apr 26, 1989 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 26, 1989
- Review
- 28 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK892057 Ohmeda Tec 5 Continuous Flow VaporizerOhmeda Medical · 1989
- Descendant · cites it directly · 2 of its ownK012924 Datex-Ohmeda Tec 7 Anesthesia VaporizerDatex-Ohmeda, Inc. · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK031027 Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)Datex-Ohmeda, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK172702 Tec 820, Tec 850Datex-Ohmeda, Inc. · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK051666 Gav - General Anaesthetic VaporizerGeneral Anaesthetic Services Limited · 2005
Most influential descendants
Showing 4 of 4 · See all- K012924Datex-Ohmeda Tec 7 Anesthesia VaporizerDatex-Ohmeda, Inc. · 2002 · cites it directly2descendants
- K031027Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)Datex-Ohmeda, Inc. · 2003 · cites it directly1descendant
- K172702Tec 820, Tec 850Datex-Ohmeda, Inc. · 2018 · 2 generations on0descendants
- K051666Gav - General Anaesthetic VaporizerGeneral Anaesthetic Services Limited · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892057 | Ohmeda Tec 5 Continuous Flow Vaporizer | Ohmeda Medical | 1989 | — |
| +1 | K012924 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer | Datex-Ohmeda, Inc. | 2002 | 1 |
| +1 | K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane) | Datex-Ohmeda, Inc. | 2003 | — |
| +2 | K172702 | Tec 820, Tec 850 | Datex-Ohmeda, Inc. | 2018 | 4 |
| +1 | K051666 | Gav - General Anaesthetic Vaporizer | General Anaesthetic Services Limited | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012924 (Datex-Ohmeda, Inc., 2002) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K892057 · printed Nov 5, 2026
Cite this page
510(k) Report. “K892057: Ohmeda Tec 5 Continuous Flow Vaporizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K892057
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026