510(k) · Cleared
ClearedSigma Alpha Vaporizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penlon Limited · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on May 10, 2006 as substantially equivalent to K002343 (Penlon, Ltd., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- May 10, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940255 (1994). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK940255 Hyperinflation Bag SystemNutec, Inc. · 1994
- 2 generations backK971923 Drager-Vapor 2000Draeger Medical, Inc. · 1997 · Recalled (Class I)
- 1 generation backK042276 D-VaporDraeger Medical, Inc. · 2004 · Recalled
- This deviceK060331 Sigma Alpha VaporizerPenlon Limited · 2006
Class I recalls in this family
- K971923 Drager-Vapor 20002 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940255 | Hyperinflation Bag System | Nutec, Inc. | 1994 | — |
| −2 | K971923 | Drager-Vapor 2000 | Draeger Medical, Inc. | 1997 | Class I |
| −1 | K042276 | D-Vapor | Draeger Medical, Inc. | 2004 | 1 |
| 0 (this device) | K060331 | Sigma Alpha Vaporizer | Penlon Limited | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K002343 | Sigma DeltaSummary page 1…80 7. Legally marketed predicate devices to which substantial equivalence is claimed: 1. Penlon Limited Sigma Delta Vaporizer - FDA 510(k) No. K002343 Approval to market this device given by FDA on June 8, 2001. FDA Device Classification: Class 2… | 2001 |
| * | K000275 | Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant…Summary page 1…1CFR 868.5880 FDA Product Code: CAD 2. Datex-Ohmeda Inc. Tec 6 Pius and Tec 6 Plus NAD Variant Anaesthesia Vaporizer- FDA 510(k) No. K000275 Approval to market this device given by FDA on April 12, 2000. FDA Device Classification: Class 2… | 2000 |
| * | K042276 | D-VaporSummary page 1…FDA Regulation Number: 21CFR 868.5880 FDA Product Code: CAD 3.Dr~igar Medical 0-Vapor Anaesthesia Vaporizer - FDA 510(k) No. K042276 Approval to market this device given bj FDA on September 23, 2004. FDA Device Classification: Class 2… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K971923Drager-Vapor 2000Draeger Medical, Inc. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K002343.
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 Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desfiurane - and delivers controlled concentrations of the vaporized anaesthetic agent into E fresh gas that is then breathed by the patient. The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha Vaporizer is not intendedto be used with Enflurane, Halothane, IsofluranE or Sevoflurane, or for use in a breathing circuit.…
Read the full statement (110 words)
The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desfiurane - and delivers controlled concentrations of the vaporized anaesthetic agent into E fresh gas that is then breathed by the patient.
The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients.
The Sigma Alpha Vaporizer is not intendedto be used with Enflurane, Halothane, IsofluranE or Sevoflurane, or for use in a breathing circuit.
The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualifiec trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It if supplied as a prescription device, and the labeling indicates this.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060331: Sigma Alpha Vaporizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060331
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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