510(k) · Cleared
Recalled · Class II · 2019BD Facs Sample Prep Assistant Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Cleared on Aug 2, 2013 after an 87-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Aug 2, 2013
- Review
- 87 days
- Class
- Class I
- Product code
- PER
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 PER? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | BD FACSCanto II system using the BD FACS Sample Prep Assistant III Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2019 | Class II | Z-2358-2020 | Component design/selection | The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All PER devicesPER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on RD FACSCantoTM 11 flow cytometry systems: " BD Multitest 6-Color TBNK Reagent with or without BD Trucourit Tubes " BD Multitest IMK Kit with or without BD Trucount Tubes * BD Multitest CD3 FITC/CD I6+CD56 PE/CD45 PerCP/CDI 9 APC with or without RD Trucount Tubes " BD,Multitest CD3 FITC/CDS PE/CD45 PerCP/CD4 APC with or without BD…
Read the full statement (192 words)
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on RD FACSCantoTM 11 flow cytometry systems:
" BD Multitest 6-Color TBNK Reagent with or without BD Trucourit Tubes
" BD Multitest IMK Kit with or without BD Trucount Tubes
* BD Multitest CD3 FITC/CD I6+CD56 PE/CD45 PerCP/CDI 9 APC with or without RD Trucount Tubes
" BD,Multitest CD3 FITC/CDS PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on RD FACSCaliburM flow cytometry systems:
" BD Multitest 1MK Kit with or without BD Trucount Tubes
" BD Multitest CD3 FITC/CD I6+CD56 PE/CD4S PcrCP/CDI19 APC with or without RD Trucount Tubes
" RD Multitest CD3 FITC/C08 PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes
* BD Tritest CD3/CD I 6+56/CD45 with or without BD Trucount Tubes
* BD Tritest C03/CD I 9/CD45 with or without RD Trucount Tubes
* R3D.Tritest CD3/CD4/CD45 with or without BD Trucount Tubes
* BD Tritest CD3/CDB/CD45 with or without Trucount Tubes
" BD Tritest CD4/CD8/C03 with RD Trucount Tubes
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131301: BD Facs Sample Prep Assistant Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131301
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026