510(k) · Cleared
Recalled · Class II · 2019Modification to BD Facscanto System with BD Facscanto Clinical Software
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 Feb 22, 2005 after a 26-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- Feb 22, 2005
- Review
- 26 days
- Class
- Class I
- Product code
- PER
- Recalls
- 4
- 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 system with BD FACSCanto clinical software using manual pipetting Named without a submission number | |
| † | K970616 | Mini Sampler Processor | 1997 |
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-2356-2020 | Component design/selection | The recalling firm confirmed that BD FACS Sample Prep Assistant (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… |
| Jul 8, 2019 | Class II | Z-2357-2020 | 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… |
| Feb 19, 2010 | Not classified | Z-1940-2010 | Nonconforming Material/Component | Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe |
| Oct 2, 2007 | Not classified | Z-0526-2008 | Software change control | Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance. |
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.
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?
Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3+CD8 +, CWD3CD4 4 , CD3-CD 16+and/or CD56 +, CD3YCD19 +, and CD3 +.
For in vitro diagnostic use.
For use with or without the BD FACS Sample Prep Assistant II.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050191 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050191: Modification to BD Facscanto System with BD Facscanto Clinical Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050191
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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