510(k) · Cleared
ClearedAseptimini Unit, Adu-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aseptico, Inc. · EIA Unit, Operative Dental
Cleared on Feb 20, 1991 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 20, 1991
- Review
- 79 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK905401 Aseptimini Unit, Adu-10Aseptico, Inc. · 1991
- Descendant · cites it directly · 3 of its ownK022217 Aeu-425 Transport II Portable Dental SystemAseptico, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK050201 Aeu-14CF ExpenditionAseptico, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK153636 Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016
- Descendant · 2 generations on · 0 of its ownK111907 Dynamic DU Series Portable Dental UnitShanghai Dynamic Industry Co., Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K022217Aeu-425 Transport II Portable Dental SystemAseptico, Inc. · 2002 · cites it directly3descendants
- K050201Aeu-14CF ExpenditionAseptico, Inc. · 2005 · 2 generations on1descendant
- K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016 · 3 generations on0descendants
- K111907Dynamic DU Series Portable Dental UnitShanghai Dynamic Industry Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905401 | Aseptimini Unit, Adu-10 | Aseptico, Inc. | 1991 | — |
| +1 | K022217 | Aeu-425 Transport II Portable Dental System | Aseptico, Inc. | 2002 | — |
| +2 | K050201 | Aeu-14CF Expendition | Aseptico, Inc. | 2005 | — |
| +3 | K153636 | Liberator Powered Wheelchair with Solar Companion | Solar Mobilityllc | 2016 | — |
| +2 | K111907 | Dynamic DU Series Portable Dental Unit | Shanghai Dynamic Industry Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022217 | Aeu-425 Transport II Portable Dental System | 2002 | 3 |
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, K022217 (Aseptico, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K905401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905401: Aseptimini Unit, Adu-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905401
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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