FDA product code · Microbiology
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
5 FDA decisions since 2013. 3 recalls name this code, 0 of them Class I. The most-cited predicate is DEN130013, named by 3 later devices.
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PEX 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 · PEX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PEX
Too few PEX 510(k)s in any year since 2007 to give a median.
Recalls per year · PEX
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEX
4in 2021
MAUDE reports naming product code PEX, 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 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 48 |
| 2017 | 2 | — | 0 | 94 |
| 2018 | 0 | — | 0 | 66 |
| 2019 | 0 | — | 0 | 107 |
| 2020 | 0 | — | 0 | 89 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in PEX? 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) Report