510(k) · Cleared
ClearedFacs Loader System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Immunocytometry Systems · GKZ Counter, Differential Cell
Cleared on Nov 20, 1995 as substantially equivalent to K913192 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) and 2 other predicates after a 129-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 20, 1995
- Review
- 129 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K880636 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880636 Reticcount SoftwareBd Becton Dickinson Vacutainer Systems Preanalytic · 1988 · Recalled
- This deviceK953302 Facs Loader SystemBecton Dickinson Immunocytometry Systems · 1995
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880636 | Reticcount Software | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | 1 |
| 0 (this device) | K953302 | Facs Loader System | Becton Dickinson Immunocytometry Systems | 1995 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913192 | Simultest (TM) Imk-LymphocyteSummary page 1…sample tubes to the cpometer in previously cleared applications for immunophenoty ping and reticulocyte enumeration. These include Simultes r’” reagent systems (such as K913 192 and K923790) and the Retie-COUNT w system (most recently cleared as K880636). Descritxion of the Device (21 CFR 807.92(a)(4)) T… | 1992 |
| * | K923790 | Facsort Flow CytometerSummary page 1…to the cpometer in previously cleared applications for immunophenoty ping and reticulocyte enumeration. These include Simultes r’” reagent systems (such as K913 192 and K923790) and the Retie-COUNT w system (most recently cleared as K880636). Descritxion of the Device (21 CFR 807.92(a)(4)) The Becton Di… | 1993 |
| * | K880636 | Reticcount SoftwareSummary page 1…enoty ping and reticulocyte enumeration. These include Simultes r’” reagent systems (such as K913 192 and K923790) and the Retie-COUNT w system (most recently cleared as K880636). Descritxion of the Device (21 CFR 807.92(a)(4)) The Becton Dickinson FACS Loader is a computer-controlled sample handling dev… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K913192.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The FACS Loader is intended for use as an accessory to the Becton Dickinson family of flow cytometers for the purpose of handling prepared blood samples for introduction to the cytometer. It is used in applications for immunophenotyping and reticulocyte enumeration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K953302 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953302: Facs Loader System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953302
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026