510(k) · Cleared
Recalled · Class II · 2024Tec 820, Tec 850
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 4, 2018 as substantially equivalent to K031027 (Datex-Ohmeda, Inc., 2003) and 1 other predicate after a 119-day review. Its family tree reaches back 3 generations to 1989. It has been recalled 4 times.
- Decided
- Jan 4, 2018
- Review
- 119 days
- Class
- Class II
- Product code
- CAD
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K892057 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK892057 Ohmeda Tec 5 Continuous Flow VaporizerOhmeda Medical · 1989
- 2 generations backK012924 Datex-Ohmeda Tec 7 Anesthesia VaporizerDatex-Ohmeda, Inc. · 2002 · Recalled
- 1 generation backK031027 Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)Datex-Ohmeda, Inc. · 2003
- This deviceK172702 Tec 820, Tec 850Datex-Ohmeda, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K892057 | Ohmeda Tec 5 Continuous Flow Vaporizer | Ohmeda Medical | 1989 | — |
| −2 | 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 | — |
| 0 (this device) | K172702 | Tec 820, Tec 850 | Datex-Ohmeda, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)Summary page 4…de Name: Tec 820, Tec 850 Common/Usual Name: Vaporizer, Anesthesia Classification Names: 21CFR868.5880 Product Code: CAD Predicate Device(s): Tec 7 (K031027 and K012924) Device Description: The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed… | 2003 |
| * | K012924 | Datex-Ohmeda Tec 7 Anesthesia VaporizerSummary page 4…820, Tec 850 Common/Usual Name: Vaporizer, Anesthesia Classification Names: 21CFR868.5880 Product Code: CAD Predicate Device(s): Tec 7 (K031027 and K012924) Device Description: The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed for the mete… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2024 | Class II | Z-0815-2025 | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Class II | Z-0818-2025 | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Class II | Z-0816-2025 | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
| Nov 18, 2024 | Class II | Z-0817-2025 | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All CAD devicesCAD Vaporizer, Anesthesia, Non-Heated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. 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 for use only with General Electric's Selectatec Series Manifolds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172702 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172702: Tec 820, Tec 850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172702
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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