510(k) · Cleared
Recalled · 2004Bio-Tek Automated Microplate Washer Model EL403
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Tek Instruments, Inc. · JTC Device, Microtiter Diluting/Dispensing
Cleared on Dec 2, 1988 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Dec 2, 1988
- Review
- 63 days
- Class
- Class I
- Product code
- JTC
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 JTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2004 | Not classified | Z-0703-05 | Other | When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JTC devicesJTC Device, Microtiter Diluting/Dispensing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JTC
FDA has decided no JTC device since 2007.
Median 510(k) review, days · JTC
Too few JTC 510(k)s in any year since 2007 to give a median.
Recalls per year · JTC
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTC
8in 2025
MAUDE reports naming product code JTC, 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 | 0 | — | 1 | 1,118 |
| 2008 | 0 | — | 1 | 919 |
| 2009 | 0 | — | 1 | 388 |
| 2010 | 0 | — | 0 | 190 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 102 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K884125 · printed Nov 5, 2026
Cite this page
510(k) Report. “K884125: Bio-Tek Automated Microplate Washer Model EL403.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K884125
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026