510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854190Substantially Equivalent

Cantrol Spinal Fluid Control

Canyon Diagnostics, Inc., Anaheim CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854190 is the FDA 510(k) clearance record for CANTROL SPINAL FLUID CONTROL, a class I device, cleared for Canyon Diagnostics, Inc. on under FDA product code DFI (Total Spinal-Fluid, Antigen, Antiserum, Control). FDA records list 9 510(k) clearances for Canyon Diagnostics, Inc., from to . As of , FDA records show no recalls naming K854190.

Clearance record

Decision date
Received
(41 days to decision)
Product code
DFI Total Spinal-Fluid, Antigen, Antiserum, Control
Regulation
21 CFR 866.5860
Device class
Class I
Review panel
Immunology
Applicant
Canyon Diagnostics, Inc. 4081 E. La Palma Ave., Unit F, Anaheim CA
Third party review
No

Clearances, product code DFI

Trailing 12 months

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

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