510(k) Report

FDA applicant

Ispg, Inc.

New Milford, CT4 decisions1995–20010 recalls

FDA records 4 decisions for Ispg, Inc. (New Milford, CT) from 1995 to 2001: 4 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FCG (Biopsy Needle). 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 Ispg, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ispg, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ispg, 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?

  • FMFSyringe, Piston2decisions
  • FCGBiopsy Needle1decision
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision

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.

  • K012358Chiba NeedleIspg, Inc. · 20011cites it

What has FDA decided for it lately?

  • K012358Chiba NeedleIspg, Inc. · 2001
  • K962886Anesthesia Conduction NeedleIspg, Inc. · 1996
  • K962042Glass SyringeIspg, Inc. · 1996
  • K950133Hypodermic Syringe PistonIspg, Inc. · 1995

All 4 as Ispg, Inc. →