510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083081Substantially Equivalent

Modification to Securacath, Model: Spk01

Interrad Medical Inc, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083081 is the FDA 510(k) clearance record for MODIFICATION TO SECURACATH, MODEL: SPK01, a class II device, cleared for Interrad Medical, Inc. on under FDA product code OKC (Implanted Subcutaneous Securement Catheter). FDA's definition for product code OKC reads: "Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site". FDA records list 7 510(k) clearances for Interrad Medical, Inc., from to . As of , FDA records show no recalls naming K083081.

Clearance record

Decision date
Received
(139 days to decision)
Product code
OKC Implanted Subcutaneous Securement Catheter
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Interrad Medical, Inc. 18555 37th Ave. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OKC

Trailing 12 months

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

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