510(k) Report

FDA applicant

Interrad Medical, Inc.

Plymouth, MN7 decisions2008–20210 recalls

FDA records 7 decisions for Interrad Medical, Inc. (Plymouth, MN) from 2008 to 2021: 7 510(k) clearances. Most are in product codes OKC (Implanted Subcutaneous Securement Catheter) and KMK (Device, Intravascular Catheter Securement). Its devices cite 13 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Interrad Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 12009: 12010: 12012: 12018: 12019: 12021: 1
2008high 1 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Interrad Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Interrad Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OKCImplanted Subcutaneous Securement Catheter5decisions
  • KMKDevice, Intravascular Catheter Securement1decision
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision

Whose devices does it build on?

Its devices cite 13 predicates; 7 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082047Securacath Catheter, Model SPK01Interrad Medical, Inc. · 20082cite it
  • K120935SecuracathInterrad Medical, Inc. · 20121cites it
  • K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 20091cites it
  • K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc. · 20191cites it
  • K092306Securacath UniversalInterrad Medical, Inc. · 20101cites it
  • K180769SecurAcathInterrad Medical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K210629SecurAcathInterrad Medical, Inc. · 2021
  • K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc. · 2019
  • K180769SecurAcathInterrad Medical, Inc. · 2018
  • K120935SecuracathInterrad Medical, Inc. · 2012
  • K092306Securacath UniversalInterrad Medical, Inc. · 2010
  • K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
  • K082047Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008

All 7 as Interrad Medical, Inc. →