510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905416Substantially Equivalent

Vessel Dilator

The R Group, Gainesvilles FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905416 is the FDA 510(k) clearance record for VESSEL DILATOR, a class II device, cleared for The R Group on under FDA product code DRE (Dilator, Vessel, For Percutaneous Catheterization). FDA records list 4 510(k) clearances for The R Group, from to . As of , FDA records show no recalls naming K905416.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DRE Dilator, Vessel, For Percutaneous Catheterization
Regulation
21 CFR 870.1310
Device class
Class II
Review panel
Cardiovascular
Applicant
The R Group P.O. Box 7235 Suite W4, Gainesvilles FL
Third party review
No

Clearances, product code DRE

Trailing 12 months
2 clearances under product code DRE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260