510(k) Report

FDA product code · Hematology

Flow Cytometric Test System For Hematopoietic Neoplasms

PWDClass II21 CFR 864.7010510(k) required2 decisions since 20170 recalls

2 FDA decisions since 2017. No recall names this code. The most-cited predicate is K183592, named by 1 later device.

Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a 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's lymphoma, myeloma, myelodysplastic…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, hematology panel

Twenty years of PWD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PWD

1in 2019

2017: 12019: 1
2007high 1 (2017) · low 0 (2007)2026

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

2020: 22021: 1
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code PWD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20191—00
20200—02
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PWD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PWD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PWD devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter · 20191cites it
  • DEN160047ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman Coulter · 20171cites it

Which PWD devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter · 20196generations

What has FDA decided in PWD lately?

  • K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter · 2019
  • DEN160047ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman Coulter · 2017

All 2 PWD decisions →