FDA product code · Clinical chemistry
Instrumentation For Clinical Multiplex Test Systems
FDA lists NSU as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 13 FDA decisions since 2007. 11 recalls name this code, 0 of them Class I. The most-cited predicate is K070597, named by 3 later devices.
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NSU at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NSU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NSU
77in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NSU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NSU
18in 2025
MAUDE reports naming product code NSU, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 85 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 3 | 77 | 0 | 30 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 4 | 3 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 24 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
Planning a device in NSU? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 862.2570.