510(k) · Cleared
ClearedKeyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454
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 Mar 3, 2006 as substantially equivalent to K945993 (Southmedic, Inc., 1995) after a 71-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Mar 3, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- CAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945993 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK945993 VapofilSouthmedic, Inc. · 1995 · Recalled
- This deviceK053564 Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454Penlon Limited · 2006
- Descendant · cites it directly · 0 of its ownK110608 Sevoflurane Vaporizer AdaptorPiramal Critcal Care, Inc (Formerly Minrad, Inc) · 2011
Most influential descendants
Showing 1 of 1 · See all- K110608Sevoflurane Vaporizer AdaptorPiramal Critcal Care, Inc (Formerly Minrad, Inc) · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945993 | Vapofil | Southmedic, Inc. | 1995 | 2 |
| 0 (this device) | K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454 | Penlon Limited | 2006 | — |
| +1 | K110608 | Sevoflurane Vaporizer Adaptor | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K945993 | VapofilSummary page 1…eted predicate device to which substantial equivalence is claimed: Southmedic, Inc. Vapofil Keyed Agent adaptor (Catalogue No. 8907)- FDA 510(k) No. K945993 Approval to market this device given by FDA on February 22, 1995. FDA Device Classification: Class 2 FDA Reg… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110608 | Sevoflurane Vaporizer Adaptor | 2011 | 0 |
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 a recall.
- Of its descendants, K110608 (Piramal Critcal Care, Inc (Formerly Minrad, Inc), 2011) has gone furthest, with 0 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 | — |
What is it indicated for?
The Keyed Filler Bottle Adaptor is intended to be used to enable the bottle, in which the anaesthetic agent is supplied by the pharmaceutical company, to be connected to the keyed filler port of an anaesthetic vaporizer. The Keyed Filler Bottle Adaptor provides a flexible connection that allows the liquid agent to be filled into, and drained from, the vaporizer by gravity. It is indicated for use with bottles of Halothane, Enflurane, Isoflurane and…
Read the full statement (133 words)
The Keyed Filler Bottle Adaptor is intended to be used to enable the bottle, in which the anaesthetic agent is supplied by the pharmaceutical company, to be connected to the keyed filler port of an anaesthetic vaporizer. The Keyed Filler Bottle Adaptor provides a flexible connection that allows the liquid agent to be filled into, and drained from, the vaporizer by gravity.
It is indicated for use with bottles of Halothane, Enflurane, Isoflurane and Sevoflurane that provide anaesthesia, via a vaporizer, to a patient connected to an anaesthetic machine.
The Keyed Filler Bottle Adaptor is an accessory to a restricted medical device and is intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053564: Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053564
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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