510(k) Report

FDA applicant

Distronic Sterile Products, Inc.

Portsmouth, NH8 decisions1995–19960 recalls

FDA records 8 decisions for Distronic Sterile Products, Inc. (Portsmouth, NH) from 1995 to 1996: 8 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FPK (Tubing, Fluid Delivery). 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 Distronic Sterile Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Distronic Sterile Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Distronic Sterile Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Distronic Sterile Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FPASet, Administration, Intravascular5decisions
  • FPKTubing, Fluid Delivery2decisions
  • FMGStopcock, I.V. Set1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K950597Core-Resistant Huber Infusion Set with Y-SiteDistronic Sterile Products, Inc. · 19952cite it

What has FDA decided for it lately?

  • K955709Winged & Subcutaneous Infusion SetsDistronic Sterile Products, Inc. · 1996
  • K955732Vented Solution SetDistronic Sterile Products, Inc. · 1996
  • K954984Minibore Stopcock SetDistronic Sterile Products, Inc. · 1996
  • K954983Extension Set with Check ValveDistronic Sterile Products, Inc. · 1996
  • K952664Solution Administration SetDistronic Sterile Products, Inc. · 1995
  • K950597Core-Resistant Huber Infusion Set with Y-SiteDistronic Sterile Products, Inc. · 1995
  • K95266360 Micro Volume Extension Set W/.22 Micron Filter, 21 Extension Set W/1.2 Mivton Gilyrt, Inj. Site, ClampDistronic Sterile Products, Inc. · 1995
  • K945184Intravascular Administration SetDistronic Sterile Products, Inc. · 1995

All 8 as Distronic Sterile Products, Inc. →