510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K920135Substantially Equivalent

Medroyal Angiographic Control Syringe

Medroyal, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920135 is the FDA 510(k) clearance record for MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE, a class II device, cleared for Medroyal, Inc. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list one 510(k) clearance for Medroyal, Inc. As of , FDA records show no recalls naming K920135.

Clearance record

Decision date
Received
(193 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Medroyal, Inc. 200 Debusk Ln., Powell TN
510(k) summary
Statement
Third party review
No

Clearances, product code DXT

Trailing 12 months
7 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261