FDA product code · Clinical chemistry
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
FDA lists PER 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. 3 FDA decisions since 2005. 2 recalls name this code, 0 of them Class I.
Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PER 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 · PER
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PER
Too few PER 510(k)s in any year since 2007 to give a median.
Recalls per year · PER
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PER
6in 2025
MAUDE reports naming product code PER, 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 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 1 | 3 |
| 2025 | 0 | — | 1 | 6 |
| 2026 | 0 | — | 0 | — |
Planning a device in PER? 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 862.2750.