510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191496Substantially Equivalent

TDS Standard Solution

Mesa Laboratories Inc, Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191496 is the FDA 510(k) clearance record for TDS Standard Solution, a class II device, cleared for Mesa Laboratories, Inc. on under FDA product code FKH (Solution-Test Standard-Conductivity, Dialysis). FDA records list 9 510(k) clearances for Mesa Laboratories, Inc., from to . As of , FDA records show no recalls naming K191496.

Clearance record

Decision date
Received
(61 days to decision)
Product code
FKH Solution-Test Standard-Conductivity, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mesa Laboratories, Inc. 12100 W. 6th Ave., Lakewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FKH

Trailing 12 months

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

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