510(k) · Cleared
ClearedUnicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter · QFS Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
Cleared on Mar 18, 2019 as substantially equivalent to K162827 (bioMerieux, Inc., 2017) and 2 other predicates after a 273-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 18, 2019
- Review
- 273 days
- Class
- Class II
- Product code
- QFS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K912133 (1991). 8 ancestors in all, the oldest K885028 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK912133 PX Coulter (R) Cell ControlCoulter Electronics, Inc. · 1991
- 2 generations backK060464 Coulter 5C Cell ControlBeckman Coulter, Inc. · 2006
- 1 generation backK081822 Coulter 6C Cell Control, Models 628027 & A59925Beckman Coulter, Inc. · 2009
- This deviceK181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator…Beckman Coulter · 2019
- Descendant · cites it directly · 1 of its ownK193124 Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK240252 UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH…Beckman Coulter, Inc. · 2024 · 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 |
|---|---|---|---|---|---|
| −3 | K912133 | PX Coulter (R) Cell Control | Coulter Electronics, Inc. | 1991 | — |
| −2 | K060464 | Coulter 5C Cell Control | Beckman Coulter, Inc. | 2006 | — |
| −1 | K081822 | Coulter 6C Cell Control, Models 628027 & A59925 | Beckman Coulter, Inc. | 2009 | — |
| 0 (this device) | K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter | 2019 | — |
| +1 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020 | 1 |
| +2 | K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer… | Beckman Coulter, Inc. | 2024 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
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 QFS? 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? (3)
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 |
|---|---|---|---|
| * | K162827 | Vidas B.R.a.H.M.S. PCT (PCT)Summary page 5…Number Cleared Code Class II VIDAS BRAHMS K162827 02/23/2017 (Special 866.3215 PMT PCT (PCT) Controls) ___… | 2017 |
| * | K081822 | Coulter 6C Cell Control, Models 628027 & A59925Summary page 8…ll Control (6C Cell Control) control that enables monitoring of system 864.8625, Hematology, Control (cleared under K081822) performance for CBC, Diff, NRBC, MDW and LDW Quality Control (K081822)… | 2009 |
| * | K885028 | Coulter 5P ControlSummary page 9…n Existing Product COULTER LATRON CP-X is a suspension of stable Class II, GKL, COULTER Latron CP-X Control (cleared under K885028) polystyrene particles of uniform size with a diameter 864.5220, Hematology, CP-X Control… | 1989 |
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 |
|---|---|---|---|
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | 2020 | 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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K193124 (Beckman Coulter, 2020) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K162827.
How does its category compare?
All QFS devicesQFS Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFS
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QFS
Too few QFS 510(k)s in any year since 2007 to give a median.
Recalls per year · QFS
No recall names QFS since 2007.
Adverse event reports per year · QFS
No MAUDE report names QFS since 2007.
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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 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 Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered. MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with…
Read the full statement (189 words)
The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.
MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.
MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.
MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.
The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181599: Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181599
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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