510(k) · Cleared
ClearedAeu-14CF Expendition
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 Mar 18, 2005 as substantially equivalent to K022217 (Aseptico, Inc., 2002) after a 49-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Mar 18, 2005
- Review
- 49 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905401 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK905401 Aseptimini Unit, Adu-10Aseptico, Inc. · 1991
- 1 generation backK022217 Aeu-425 Transport II Portable Dental SystemAseptico, Inc. · 2002
- This deviceK050201 Aeu-14CF ExpenditionAseptico, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK153636 Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016
Most influential descendants
Showing 1 of 1 · See all- K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905401 | Aseptimini Unit, Adu-10 | Aseptico, Inc. | 1991 | — |
| −1 | K022217 | Aeu-425 Transport II Portable Dental System | Aseptico, Inc. | 2002 | — |
| 0 (this device) | K050201 | Aeu-14CF Expendition | Aseptico, Inc. | 2005 | — |
| +1 | K153636 | Liberator Powered Wheelchair with Solar Companion | Solar Mobilityllc | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K022217 | Aeu-425 Transport II Portable Dental SystemSummary page 1…panel is also provided for recharging the internal batteries when other sources are not available. Features of Substantial Equivalence to Aseptico Model AEU-425 r510(k) K0222171 1) Autoclavable low-voltage electric micro motor 2) Forward, reverse, and speed control for handpiece motor 3… | 2002 |
| † | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | 2002 |
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 |
|---|---|---|---|
| K153636 | Liberator Powered Wheelchair with Solar Companion | 2016 | 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?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153636 (Solar Mobilityllc, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022217.
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?
The EXPEDITION offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is suitable for performing general dental procedures anywhere there is a suitable power source. Additionally, the EXPEDITION may be operated on internal batteries, which can be recharged using a detachable solar panel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050201: Aeu-14CF Expendition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050201
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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