510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812639Substantially Equivalent

Unicuff

Frontier Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812639 is the FDA 510(k) clearance record for UNICUFF, a class II device, cleared for Frontier Products on under FDA product code DXP (Transducer, Vessel Occlusion). FDA records list 4 510(k) clearances for Frontier Products, from to . As of , FDA records show no recalls naming K812639.

Clearance record

Decision date
Received
(16 days to decision)
Product code
DXP Transducer, Vessel Occlusion
Regulation
21 CFR 870.2890
Device class
Class II
Review panel
Cardiovascular
Applicant
Frontier Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DXP

Trailing 12 months

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

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