510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070911Substantially Equivalent

Std Med Primo Port

Std Med, Inc., Ayer MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070911 is the FDA 510(k) clearance record for STD MED PRIMO PORT, a class II device, cleared for Std Med, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 2 510(k) clearances for Std Med, Inc., from to . As of , FDA records show no recalls naming K070911.

Clearance record

Decision date
Received
(130 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Std Med, Inc. 5 Whitcomb Ave., Ayer MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJT

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