510(k) Report

FDA applicant

Advanced Bioresearch Assoc.

Rockville, MD3 decisions1995–19950 recalls

FDA records 3 decisions for Advanced Bioresearch Assoc. (Rockville, MD) in 1995: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and FPA (Set, Administration, Intravascular). 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 Advanced Bioresearch Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Bioresearch Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Bioresearch Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Bioresearch Assoc.’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?

  • FLLContinuous Measurement Thermometer1decision
  • FPASet, Administration, Intravascular1decision
  • EYQGarment, Protective, For Incontinence1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K943695SuretempAdvanced Bioresearch Assoc. · 19954cite it

What has FDA decided for it lately?

  • K950784Dristar Urinary Incontinence Management SystemAdvanced Bioresearch Assoc. · 1995
  • K943695SuretempAdvanced Bioresearch Assoc. · 1995
  • K944619I.V.I.D. Fluid Administration Set MarkerAdvanced Bioresearch Assoc. · 1995

All 3 as Advanced Bioresearch Assoc. →