510(k) · Cleared
ClearedSiemens Sevoflurane Vaporizer SV 953
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Aug 19, 1998 as substantially equivalent to K841157 (Siemens Elema AB, 1984) after a 163-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Aug 19, 1998
- Review
- 163 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K841157 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK841157 Halothane Vaporizer 950, EnfluraneSiemens Elema AB · 1984
- This deviceK980884 Siemens Sevoflurane Vaporizer SV 953Siemens Medical Solutions USA, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841157 | Halothane Vaporizer 950, Enflurane | Siemens Elema AB | 1984 | — |
| 0 (this device) | K980884 | Siemens Sevoflurane Vaporizer SV 953 | Siemens Medical Solutions USA, Inc. | 1998 | — |
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? (1)
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 |
|---|---|---|---|
| * | K841157 | Halothane Vaporizer 950, EnfluraneSummary page 2…951/952, i.e Halothane Vaporizer 950, Enflurane Vaporizer 951, Isoflurane Vaporizer 952, they were found Substantially Equivalent on June 7, 1984 (Premarket Notification K841157). Device Description The Sevoflurane Vaporizer 953 is an anesthetic vaporizer used together with Siemens Servo Ventilator 900 i… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K841157.
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?
Purpose and function of the Sevoflurane Vaporizer SV 953: The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liquid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery. Intended Operator: The Sevoflurane Vaporizer SV953 is intended to be used by Healthcare providers, i.e. Physicians, Nurses and Technicians. Intended Patient…
Read the full statement (134 words)
Purpose and function of the Sevoflurane Vaporizer SV 953:
The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liquid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery.
Intended Operator:
The Sevoflurane Vaporizer SV953 is intended to be used by Healthcare providers, i.e. Physicians, Nurses and Technicians.
Intended Patient Populations:
The Sevoflurane Vaporizer SV953 is intended for general and critical ventilatory to be used on Adult, Pediatric, Infant and Neonatal populations.
Intended Use Environment:
The Sevoflurane Vaporizer SV953 is intended to be used in the environment where patient care is provided by Healthcare Professionals. The unit is designed to be used at the bedside. It is not intended for transport use in ambulances or helicopters in the U.S. market.
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/K980884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980884: Siemens Sevoflurane Vaporizer SV 953.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980884
Report an extraction error
Are you the manufacturer?
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