FDA product code · Hematology
Separator, Automated, Blood Cell, Diagnostic
10 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 GKT 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 · GKT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GKT
Too few GKT 510(k)s in any year since 2007 to give a median.
Recalls per year · GKT
No recall names GKT since 2007.
Adverse event reports per year · GKT
229in 2025
MAUDE reports naming product code GKT, 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 | 8 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 77 |
| 2012 | 0 | — | 0 | 551 |
| 2013 | 0 | — | 0 | 460 |
| 2014 | 0 | — | 0 | 371 |
| 2015 | 0 | — | 0 | 357 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 0 | — | 0 | 327 |
| 2018 | 0 | — | 0 | 354 |
| 2019 | 0 | — | 0 | 434 |
| 2020 | 1 | — | 0 | 561 |
| 2021 | 0 | — | 0 | 490 |
| 2022 | 0 | — | 0 | 445 |
| 2023 | 0 | — | 0 | 343 |
| 2024 | 0 | — | 0 | 444 |
| 2025 | 0 | — | 0 | 229 |
| 2026 | 0 | — | 0 | — |
Planning a device in GKT? 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 864.9245.