510(k) · Cleared
ClearedAeu-425 Transport II Portable Dental System
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 Oct 24, 2002 as substantially equivalent to K905401 (Aseptico, Inc., 1991) after a 108-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Oct 24, 2002
- Review
- 108 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905401 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK905401 Aseptimini Unit, Adu-10Aseptico, Inc. · 1991
- This deviceK022217 Aeu-425 Transport II Portable Dental SystemAseptico, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK050201 Aeu-14CF ExpenditionAseptico, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK153636 Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016
- Descendant · cites it directly · 0 of its ownK111907 Dynamic DU Series Portable Dental UnitShanghai Dynamic Industry Co., Ltd. · 2011
Most influential descendants
Showing 3 of 3 · See all- K050201Aeu-14CF ExpenditionAseptico, Inc. · 2005 · cites it directly1descendant
- K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016 · 2 generations on0descendants
- K111907Dynamic DU Series Portable Dental UnitShanghai Dynamic Industry Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905401 | Aseptimini Unit, Adu-10 | Aseptico, Inc. | 1991 | — |
| 0 (this device) | K022217 | Aeu-425 Transport II Portable Dental System | Aseptico, Inc. | 2002 | — |
| +1 | K050201 | Aeu-14CF Expendition | Aseptico, Inc. | 2005 | — |
| +2 | K153636 | Liberator Powered Wheelchair with Solar Companion | Solar Mobilityllc | 2016 | — |
| +1 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K905401 | Aseptimini Unit, Adu-10Summary page 1…ction systems employed by the AEU-425 are substantially equivalent to the previously marketed device “Asepti-mini” ADU-10 covered by 51O(k) K905401. b. All water, waste water lines are made of polyethylene or polyurethane. Containers are made form eit… | 1991 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K050201 (Aseptico, Inc., 2005) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
Transport II offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is ideally suited for performing general dental procedures anywhere there is a suitable power source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022217: Aeu-425 Transport II Portable Dental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022217
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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