510(k) Report

FDA applicant

Premier Medical

Philadelphia, PA3 decisions1988–19900 recalls

FDA records 3 decisions for Premier Medical (Philadelphia, PA) from 1988 to 1990: 3 510(k) clearances. Most are in product codes LRY (Punch, Surgical) and EJP (Articulators). 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 and plastic surgery panel, where it files most

How often FDA has decided Premier Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Premier Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Premier Medical 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?

  • LRYPunch, Surgical1decision
  • EJPArticulators1decision
  • JOHTube Tracheostomy And Tube Cuff1decision

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.

  • K896303Biopsy PunchPremier Medical · 19901cites it

What has FDA decided for it lately?

  • K896303Biopsy PunchPremier Medical · 1990
  • K894050Modified Decannulation StopperPremier Medical · 1989
  • K884418Premier Die-Trak ArticulatorPremier Medical · 1988

All 3 as Premier Medical →