510(k) Report

FDA applicant

Innovations IN Access, Inc.

West Linn, OR1 decision1992–19920 recalls

FDA records 1 decision for Innovations IN Access, Inc. (West Linn, OR) in 1992: 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 IN Access, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovations IN Access, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovations IN Access, Inc. by year, 2007–2026Sources: 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 1 time; 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.

  • K920614Hemo-BandInnovations IN Access, Inc. · 19921cites it

What has FDA decided for it lately?

  • K920614Hemo-BandInnovations IN Access, Inc. · 1992

The one decision as Innovations IN 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 by Necessity, Inc. 1Innovations For Access, Inc. 1