FDA product code · Microbiology
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
1 FDA decision since 2021. 6 recalls name this code, 0 of them Class I.
A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QPO 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 · QPO
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QPO
Too few QPO 510(k)s in any year since 2007 to give a median.
Recalls per year · QPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QPO
No MAUDE report names QPO since 2007.
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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 6 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QPO? 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