510(k) · Cleared
Recalled · Class II · 2017TQ-Prep Workstation, Prepplus 2 Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Cleared on Jul 15, 2013 as substantially equivalent to K874188 (Coulter Electronics, Inc., 1988) after a 164-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 2 times.
- Decided
- Jul 15, 2013
- Review
- 164 days
- Class
- Class I
- Product code
- PER
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874188 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK874188 Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK StaCoulter Electronics, Inc. · 1988
- This deviceK130253 TQ-Prep Workstation, Prepplus 2 WorkstationBeckman Coulter, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874188 | Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta | Coulter Electronics, Inc. | 1988 | — |
| 0 (this device) | K130253 | TQ-Prep Workstation, Prepplus 2 Workstation | Beckman Coulter, Inc. | 2013 | — |
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? (2)
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 |
|---|---|---|---|
| * | K874188 | Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK StaSummary page 1…Candidate B Predicate Manufacturer 510(k) Number TQ-Prep Q-Prep Beckman Coulter, Inc. K874 188 PrepPlus 2 Manual Pipette Various Not applicable Beckman Coulter, Inc.… | 1988 |
| * | — | Manual Pipette 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 |
|---|---|---|---|---|
| May 22, 2017 | Class II | Z-2690-2017 | Software design | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run. |
| May 22, 2017 | Class II | Z-2689-2017 | Software design | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no 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?
The COULTER TQ-Prep Workstation is intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent Systemi and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of…
Read the full statement (172 words)
The COULTER TQ-Prep Workstation is intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent Systemi and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers.
Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described In each application's Instructions for Use. For In Vitro Diagnosic Use Only
The COULTER PrepPlus 2, when used in combinations with the COULTER TO-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVO applications on cleared Beckman Coulter flow cytometers.
Pipetting blood, cleared Beckman Coulter IVO reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For InVitro Diagnostic Use Only
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130253: TQ-Prep Workstation, Prepplus 2 Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130253
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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