510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812906Substantially Equivalent

Elvi Biclot 816

Volu Sol Medical Industries, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812906 is the FDA 510(k) clearance record for ELVI BICLOT 816, a class II device, cleared for Volu Sol Medical Industries on under FDA product code KQG (Instrument, Coagulation). FDA records list 66 510(k) clearances for Volu Sol Medical Industries, from to . As of , FDA records show no recalls naming K812906.

Clearance record

Decision date
Received
(276 days to decision)
Product code
KQG Instrument, Coagulation
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Volu Sol Medical Industries 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQG

Trailing 12 months

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

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