510(k) Report

FDA applicant

Bio-Systems Research

Lake Oswego, OR2 decisions1994–19960 recalls

FDA records 2 decisions for Bio-Systems Research (Lake Oswego, OR) from 1994 to 1996: 2 510(k) clearances. Most are in product codes EBH (Material, Impression Tray, Resin) and KPN (Alarm, Conditioned Response Enuresis). Its devices cite 1 predicate, 0 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, dental panel, where it files most

How often FDA has decided Bio-Systems Research’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Systems Research since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Systems Research 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?

  • EBHMaterial, Impression Tray, Resin1decision
  • KPNAlarm, Conditioned Response Enuresis1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K962416Drytime for Bladder Control SilentBio-Systems Research · 1996
  • K933745Permagen Universal Bonding ResinBio-Systems Research · 1994

All 2 as Bio-Systems Research →