510(k) Report

FDA applicant

Innovations For Access, Inc.

Portland, OR1 decision2009–20090 recalls

FDA records 1 decision for Innovations For Access, Inc. (Portland, OR) in 2009: 1 510(k) clearance. All are in product code KOC (Accessories, Blood Circuit, Hemodialysis). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Innovations For Access, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Innovations For Access, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KOCAccessories, Blood Circuit, Hemodialysis1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K081740Hemoband, Models HB-NS and HB-NSXLInnovations For Access, Inc. · 20092cite it

What has FDA decided for it lately?

  • K081740Hemoband, Models HB-NS and HB-NSXLInnovations For Access, Inc. · 2009

The one decision as Innovations For Access, Inc. →

Other applicant names beginning “Innovations”

FDA records each applicant name separately; these may or may not be the same firm.

Innovations For Mechanical Ventilation, Inc. 3Innovations IN Access, Inc. 1Innovations by Necessity, Inc. 1