510(k) · Cleared
Recalled · 2006Vapofil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southmedic, Inc. · CAD Vaporizer, Anesthesia, Non-Heated
Cleared on Feb 22, 1995 after a 96-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 22, 1995
- Review
- 96 days
- Class
- Class II
- Product code
- CAD
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK945993 VapofilSouthmedic, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK053564 Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454Penlon Limited · 2006
- Descendant · 2 generations on · 0 of its ownK110608 Sevoflurane Vaporizer AdaptorPiramal Critcal Care, Inc (Formerly Minrad, Inc) · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945993 | Vapofil | Southmedic, Inc. | 1995 | — |
| +1 | K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454 | Penlon Limited | 2006 | — |
| +2 | K110608 | Sevoflurane Vaporizer Adaptor | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454 | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2006 | Not classified | Z-1189-06 | Other | Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia… |
| Apr 21, 2006 | Not classified | Z-1190-06 | Other | Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053564 (Penlon Limited, 2006) has gone furthest, with 1 descendant 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/K945993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945993: Vapofil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945993
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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