510(k) · Cleared
ClearedThe Scitech One-Day Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scitech Solutions, Inc. · EIA Unit, Operative Dental
Cleared on Feb 22, 1994 after a 406-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 22, 1994
- Review
- 406 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK930144 The Scitech One-Day FilterScitech Solutions, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK963548 Dentapure Dental Unit Water Line Filter-IodinatedMrlb Intl., Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK992893 Dentapure DP 90 Cartridge, Dentapure DP 365 CartridgeMrlb Intl., Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK992868 Dentapure DP40 CartridgeMrlb Intl., Inc. · 1999
- Descendant · cites it directly · 1 of its ownK973996 Clearline Plus, Dental Waterline FilterScitech Solutions, Inc. · 1998
- Descendant · 3 generations on · 0 of its ownK232393 BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model…Proedge Dental Products, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K963548Dentapure Dental Unit Water Line Filter-IodinatedMrlb Intl., Inc. · 1997 · cites it directly6descendants
- K992893Dentapure DP 90 Cartridge, Dentapure DP 365 CartridgeMrlb Intl., Inc. · 1999 · 2 generations on1descendant
- K992868Dentapure DP40 CartridgeMrlb Intl., Inc. · 1999 · 2 generations on1descendant
- K973996Clearline Plus, Dental Waterline FilterScitech Solutions, Inc. · 1998 · cites it directly1descendant
- K232393BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180…Proedge Dental Products, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930144 | The Scitech One-Day Filter | Scitech Solutions, Inc. | 1994 | — |
| +1 | K963548 | Dentapure Dental Unit Water Line Filter-Iodinated | Mrlb Intl., Inc. | 1997 | — |
| +2 | K992893 | Dentapure DP 90 Cartridge, Dentapure DP 365 Cartridge | Mrlb Intl., Inc. | 1999 | — |
| +2 | K992868 | Dentapure DP40 Cartridge | Mrlb Intl., Inc. | 1999 | — |
| +1 | K973996 | Clearline Plus, Dental Waterline Filter | Scitech Solutions, Inc. | 1998 | — |
| +3 | K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers… | Proedge Dental Products, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2023 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
4 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, K963548 (Mrlb Intl., Inc., 1997) has gone furthest, with 6 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/K930144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K930144: The Scitech One-Day Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930144
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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