510(k) · Cleared
ClearedPenadapt 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buffalo Filter Co., Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Jun 8, 2000 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Jun 8, 2000
- Review
- 79 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK000904 Penadapt 10Buffalo Filter Co., Inc. · 2000
- Descendant · cites it directly · 20 of its ownK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- Descendant · 3 generations on · 5 of its ownK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- Descendant · 2 generations on · 4 of its ownK182772 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab…Covidien · 2018
- Descendant · 3 generations on · 4 of its ownK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K103375Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011 · cites it directly20descendants
- K120454Safeair Smoke Pencil,Lna Medical Aps · 2012 · 2 generations on8descendants
- K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on5descendants
- K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…Covidien · 2018 · 2 generations on4descendants
- K143145SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000904 | Penadapt 10 | Buffalo Filter Co., Inc. | 2000 | — |
| +1 | K103375 | Plumepen Integrated Smoke Evacuation Pencil | Medtek Devices, Inc. | 2011 | — |
| +2 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| +3 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| +2 | K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke… | Covidien | 2018 | — |
| +3 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 FYD? 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 FYD device
- #1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K103375 (Medtek Devices, Inc., 2011) has gone furthest, with 20 descendants of its own.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FYD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYD
71in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYD
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYD
15in 2025
MAUDE reports naming product code FYD, 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 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 39 |
| 2011 | 0 | — | 0 | 150 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 0 | 142 |
| 2014 | 1 | — | 0 | 71 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 71 | 0 | 11 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K000904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000904: Penadapt 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000904
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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