510(k) Report

FDA applicant

Applied Diabetes Research, Incorporated

Laguna Niguel, CA4 decisions2001–20040 recalls

FDA records 4 decisions for Applied Diabetes Research, Incorporated (Laguna Niguel, CA) from 2001 to 2004: 4 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Applied Diabetes Research, Inc.”.

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 Applied Diabetes Research, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Diabetes Research, Incorporated since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Applied Diabetes Research, Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • FRNPump, Infusion2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K024056Sureset 3.0 ML Reservoir, Model 24-103Applied Diabetes Research, Incorporated · 20032cite it
  • K012429Sureset Infusion Set, Model 8023Applied Diabetes Research, Incorporated · 20011cites it

What has FDA decided for it lately?

  • K041152Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332AApplied Diabetes Research, Inc. · 2004
  • K033099Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109Applied Diabetes Research, Incorporated · 2003
  • K024056Sureset 3.0 ML Reservoir, Model 24-103Applied Diabetes Research, Incorporated · 2003
  • K012429Sureset Infusion Set, Model 8023Applied Diabetes Research, Incorporated · 2001

All 3 as Applied Diabetes Research, Incorporated →The one decision as Applied Diabetes Research, Inc. →