510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953875Substantially Equivalent

Crit-Line Hematocrit Alert (Modification)

In-Line Diagnostics Corp., Riverdale UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953875 is the FDA 510(k) clearance record for CRIT-LINE HEMATOCRIT ALERT (MODIFICATION), a class II device, cleared for In-Line Diagnostics Corp. on under FDA product code MQS (System, Hemodialysis, Access Recirculation Monitoring). FDA records list 8 510(k) clearances for In-Line Diagnostics Corp., from to . As of , FDA records show no recalls naming K953875.

Clearance record

Decision date
Received
(391 days to decision)
Product code
MQS System, Hemodialysis, Access Recirculation Monitoring
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
In-Line Diagnostics Corp. 4646 S. 1500 W.,Suite 160, Riverdale UT
510(k) summary
Statement
Third party review
No

Clearances, product code MQS

Trailing 12 months

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

FDA records show no clearances under product code MQS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQS, 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