510(k) Report

FDA applicant

Pavel Jordan & Associates, Inc.

Orange, CA3 decisions1987–19880 recalls

FDA records 3 decisions for Pavel Jordan & Associates, Inc. (Orange, CA) from 1987 to 1988: 3 510(k) clearances. Most are in product codes KZH (Introducer, Syringe Needle) and FMF (Syringe, Piston). 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 Pavel Jordan & Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pavel Jordan & Associates, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pavel Jordan & Associates, 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?

  • KZHIntroducer, Syringe Needle2decisions
  • FMFSyringe, Piston1decision

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.

  • K883311Count-a-DosePavel Jordan & Associates, Inc. · 19881cites it

What has FDA decided for it lately?

  • K883164Instaject IIPavel Jordan & Associates, Inc. · 1988
  • K883311Count-a-DosePavel Jordan & Associates, Inc. · 1988
  • K870474InstajectPavel Jordan & Associates, Inc. · 1987

All 3 as Pavel Jordan & Associates, Inc. →