510(k) Report

FDA applicant

Precision Medical Products, Inc.

Denver, PA2 decisions2001–20030 recalls

FDA records 2 decisions for Precision Medical Products, Inc. (Denver, PA) from 2001 to 2003: 2 510(k) clearances. All are in product code SCL (Allergen And Vaccine Delivery Needles). 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 Precision Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Precision Medical Products, 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?

  • SCLAllergen And Vaccine Delivery Needles2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

  • Bd1citation

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012515Bifurcated Vaccinating NeedlePrecision Medical Products, Inc. · 20011cites it

What has FDA decided for it lately?

  • K031630Bifurcated Allergy Skin Testing NeedlePrecision Medical Products, Inc. · 2003
  • K012515Bifurcated Vaccinating NeedlePrecision Medical Products, Inc. · 2001

All 2 as Precision Medical Products, Inc. →