FDA product code · Hematology
System, Test, Automated Blood Grouping And Antibody
4 FDA decisions since 1977. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of KSZ 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 · KSZ
FDA has decided no KSZ device since 2007.
Median 510(k) review, days · KSZ
Too few KSZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KSZ
No recall names KSZ since 2007.
Adverse event reports per year · KSZ
65in 2025
MAUDE reports naming product code KSZ, 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 | 927 |
| 2008 | 0 | — | 0 | 1,047 |
| 2009 | 0 | — | 0 | 736 |
| 2010 | 0 | — | 0 | 520 |
| 2011 | 0 | — | 0 | 559 |
| 2012 | 0 | — | 0 | 586 |
| 2013 | 0 | — | 0 | 542 |
| 2014 | 0 | — | 0 | 526 |
| 2015 | 0 | — | 0 | 485 |
| 2016 | 0 | — | 0 | 620 |
| 2017 | 0 | — | 0 | 626 |
| 2018 | 0 | — | 0 | 686 |
| 2019 | 0 | — | 0 | 298 |
| 2020 | 0 | — | 0 | 75 |
| 2021 | 0 | — | 0 | 76 |
| 2022 | 0 | — | 0 | 78 |
| 2023 | 0 | — | 0 | 151 |
| 2024 | 0 | — | 0 | 66 |
| 2025 | 0 | — | 0 | 65 |
| 2026 | 0 | — | 0 | — |
Planning a device in KSZ? 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 864.9175.