510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070584Substantially Equivalent

Smart-Rod

Duoject Medical Systems, Inc., Bromont, Qc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070584 is the FDA 510(k) clearance record for SMART-ROD, a class II device, cleared for Duoject Medical Systems, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 3 510(k) clearances for Duoject Medical Systems, Inc., from to . As of , FDA records show no recalls naming K070584.

Clearance record

Decision date
Received
(398 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Duoject Medical Systems, Inc. 50 Chemin De Gaspe Complex B-5, Bromont, Qc, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260