510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011741Substantially Equivalent

Crit-Line Monitor III Tqa (Clm Tqa)

Hemametrics, Kaysville UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011741 is the FDA 510(k) clearance record for CRIT-LINE MONITOR III TQA (CLM TQA), a class II device, cleared for Hemametrics on under FDA product code FIL (System, Dialysate Delivery, Single Pass). FDA records list one 510(k) clearance for Hemametrics. As of , FDA records show no recalls naming K011741.

Clearance record

Decision date
Received
(413 days to decision)
Product code
FIL System, Dialysate Delivery, Single Pass
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hemametrics 695 N. 900 W., Kaysville UT
510(k) summary
Summary
Third party review
No

Clearances, product code FIL

Trailing 12 months

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

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