510(k) · Cleared
ClearedHalothane Vaporizer 950, Enflurane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Elema AB · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Jun 7, 1984 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Jun 7, 1984
- Review
- 80 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly. 3 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK841157 Halothane Vaporizer 950, EnfluraneSiemens Elema AB · 1984
- Descendant · cites it directly · 6 of its ownK973971 Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999
- Descendant · 2 generations on · 5 of its ownK024213 Siemens Kion Anesthesia Workstation - Extended Modes Functionality…Siemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 4 of its ownK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
- Descendant · 4 generations on · 3 of its ownK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
- Descendant · 5 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K973971Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999 · cites it directly6descendants
- K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc. · 2004 · 2 generations on5descendants
- K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011 · 3 generations on4descendants
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 4 generations on3descendants
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K841157 | Halothane Vaporizer 950, Enflurane | Siemens Elema AB | 1984 | — |
| +1 | K973971 | Kion Anesthesia System | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +2 | K024213 | Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64… | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| +3 | K102182 | Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 | Maquet Critical Care AB | 2011 | — |
| +4 | K112114 | Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40 | Maquet Critical Care AB | 2012 | Class I |
| +5 | K133958 | Flow-I Anesthesia System C20, C30 & C40 | Maquet Critical Care AB | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2014 | 1 | 1 |
| 2017 | 1 | 0 |
| 2020 | 1 | 1 |
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.
3 devices in this family have a Class I recall. 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? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K973971 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 6 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/K841157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K841157: Halothane Vaporizer 950, Enflurane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841157
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026