De Novo · Granted
GrantedClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter · PWD Flow Cytometric Test System For Hematopoietic Neoplasms
Granted on Jun 29, 2017 as a new device type through De Novo after a 269-day review. 2 later devices descend from it.
- Decided
- Jun 29, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- PWD
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN160047 ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman Coulter · 2017
- Descendant · cites it directly · 1 of its ownK183592 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios…Beckman Coulter · 2019
- Descendant · 2 generations on · 0 of its ownK232600 DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | Beckman Coulter | 2017 | — |
| +1 | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow… | Beckman Coulter | 2019 | — |
| +2 | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo 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 PWD? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | 2019 | 1 |
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?
- Of its descendants, K183592 (Beckman Coulter, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PWD devicesPWD Flow Cytometric Test System For Hematopoietic Neoplasms: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PWD
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PWD
Too few PWD 510(k)s in any year since 2007 to give a median.
Recalls per year · PWD
No recall names PWD since 2007.
Adverse event reports per year · PWD
1in 2021
MAUDE reports naming product code PWD, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ClearLLab reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC 500 flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS)…
Read the full statement (173 words)
The ClearLLab reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC 500 flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood collected in EDTA (K2 and K3EDTA), Acid Citrate Dextrose or Heparin, bone marrow collected in K2EDTA, ACD, or Heparin, and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters listed below:
- ClearLLab T1: CD2, CD56, CD7, CD5, CD45
- ClearLLab T2: CD8, CD4, CD3, CD45
- ClearLLab B1: Kappa, Lambda, CD19, CD5, CD45
- ClearLLab B2: CD20, CD10, CD19, CD38, CD45
- ClearLLab M: CD7, CD13, CD34, CD33, CD45
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160047 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160047: ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160047
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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