FDA product code · Pathology
Immunohistochemistry Reagents And Kits
FDA lists NJT as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 53 recalls name this code, 8 of them Class I.
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NJT 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 · NJT
FDA has decided no NJT device since 2007.
Median 510(k) review, days · NJT
Too few NJT 510(k)s in any year since 2007 to give a median.
Recalls per year · NJT
1in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · NJT
7in 2025
MAUDE reports naming product code NJT, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 5 | 1 |
| 2011 | 0 | — | 4 | 0 |
| 2012 | 0 | — | 13 | 3 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 0 | — | 4 | 4 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 8 (8) | 1 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 1 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 1 | 7 |
| 2026 | 0 | — | 0 | — |
Planning a device in NJT? 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 864.1860.