510(k) · Cleared
ClearedBioclear Concentrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waggoner Product Development · EIA Unit, Operative Dental
Cleared on Oct 15, 1998 as substantially equivalent to K962071 (Pelton & Crane Co., 1996) after a 167-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 15, 1998
- Review
- 167 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962071 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- This deviceK981565 Bioclear ConcentrateWaggoner Product Development · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| 0 (this device) | K981565 | Bioclear Concentrate | Waggoner Product Development | 1998 | — |
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 |
|---|---|---|---|
| * | K962071 | Spirit S1/S2Summary page 2…similar in its intended use and mode of action to the Dentosept P disinfectant, legally marketed by both Pelton & Crane Company, Charlotte, N.C. with their Spirit 1/ 2, K962071 and Siemens Company, Genmany, with their Sirona Water Purification Unit, 901672, However, we feel that BioClear Concentrate is s… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 4 other devices also cite its predicate K962071.
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?
BioClear Concentrate is intended to be diluted daily into tap water and placed in an independent dental reservoir bottle system, which would act as the sole supply of water for the Dental Operative Unit. There, the diluted BioClear Concentrate would act as a constantly present, potable, antimicrobial agent. It has been found to aid in the control of the microbial population in dental unit waterlines.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981565: Bioclear Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981565
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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