510(k) · Cleared
ClearedMLX Microtiter Plate Luminometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatech Laboratories, Inc. · JSE Culture Media, Multiple Biochemical Test
Cleared on Jul 25, 1996 as substantially equivalent to K923456 (Dynatech Laboratories, Inc., 1992) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jul 25, 1996
- Review
- 43 days
- Class
- Class I
- Product code
- JSE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915896 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK915896 Microlite Microtiter Plate Luminometer ML2250/ModiDynatech Laboratories, Inc. · 1992
- This deviceK962265 MLX Microtiter Plate LuminometerDynatech Laboratories, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK980120 Digene DML 2000 Microplate LuminometerDigene Corp. · 1998 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K980120Digene DML 2000 Microplate LuminometerDigene Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915896 | Microlite Microtiter Plate Luminometer ML2250/Modi | Dynatech Laboratories, Inc. | 1992 | — |
| 0 (this device) | K962265 | MLX Microtiter Plate Luminometer | Dynatech Laboratories, Inc. | 1996 | — |
| +1 | K980120 | Digene DML 2000 Microplate Luminometer | Digene Corp. | 1998 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 JSE? 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? (2)
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 |
|---|---|---|---|
| * | K923456 | Microlite Microtiter Plate Luminometer ML3000Summary page 1…ly marketed microplate luminometers that have received 510(k) premarket notification clearance. Specifically, the MLX is substantially equivalent to the Dynatech ML.3000(K923456) and ML2250(K915896) microplate luminometers. The MLX and the predicate luminometers have identical intended uses and there are n… | 1992 |
| * | K915896 | Microlite Microtiter Plate Luminometer ML2250/ModiSummary page 1…te luminometers that have received 510(k) premarket notification clearance. Specifically, the MLX is substantially equivalent to the Dynatech ML.3000(K923456) and ML2250(K915896) microplate luminometers. The MLX and the predicate luminometers have identical intended uses and there are no differences in tec… | 1992 |
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 |
|---|---|---|---|
| K980120 | Digene DML 2000 Microplate Luminometer | 1998 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K980120 (Digene Corp., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JSE devicesJSE Culture Media, Multiple Biochemical Test: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JSE
FDA has decided no JSE device since 2007.
Median 510(k) review, days · JSE
Too few JSE 510(k)s in any year since 2007 to give a median.
Recalls per year · JSE
No recall names JSE since 2007.
Adverse event reports per year · JSE
1in 2022
MAUDE reports naming product code JSE, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MLX measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results.
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/K962265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962265: MLX Microtiter Plate Luminometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962265
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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