510(k) Report

FDA applicant

Quality System Consulting

Carlsbad, CA1 decision1997–19970 recalls

FDA records 1 decision for Quality System Consulting (Carlsbad, CA) in 1997: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 3 predicates, 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, general hospital panel, where it files most

How often FDA has decided Quality System Consulting’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quality System Consulting since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quality System Consulting 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?

  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K972527Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 19975cite it

What has FDA decided for it lately?

  • K972527Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997

The one decision as Quality System Consulting →