510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831502Substantially Equivalent

Nephrolyte

Flaitron Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831502 is the FDA 510(k) clearance record for NEPHROLYTE, a class I device, cleared for Flaitron Laboratories, Inc. on under FDA product code KFC (Methylene Blue, Tissue Stain). FDA records list one 510(k) clearance for Flaitron Laboratories, Inc. As of , FDA records show no recalls naming K831502.

Clearance record

Decision date
Received
(68 days to decision)
Product code
KFC Methylene Blue, Tissue Stain
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Flaitron Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KFC

Trailing 12 months

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

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