510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181599Substantially Equivalent

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

Siemens Healthcare Diagnostics Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181599 is the FDA 510(k) clearance record for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application, a class II device, cleared for Beckman Coulter on under FDA product code QFS (Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment). FDA's definition for product code QFS reads: "An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW...". FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K181599.

Clearance record

Decision date
Received
(273 days to decision)
Product code
QFS Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Beckman Coulter 11800 SW 147th Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFS

Trailing 12 months

FDA records hold no clearances under product code QFS in the trailing twelve months.

FDA records show no clearances under product code QFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260