510(k) Report

FDA applicant

Exel Intl.

Culver City, CA18 decisions1986–20002 recalls

FDA records 18 decisions for Exel Intl. (Culver City, CA) from 1986 to 2000: 18 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMI (Needle, Hypodermic, Single Lumen). 2 recalls are 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 Exel Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Exel Intl. since 2007.

Recalls per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Exel Intl.’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, Intravascular6decisions
  • FMINeedle, Hypodermic, Single Lumen4decisions
  • FIENeedle, Fistula1decision
  • FDZAttachment, Eyepiece, For Insertion Of Prescription Lens1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature1decision

Also: FMG (1), GIM (1), DZM (1), FMF (1).

Who builds on its devices?

Later devices cite its devices 10 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.

  • K895769Exel Huber NeedleExel Intl. · 19902cite it
  • K861152Exel Vacuum Blood Collecting SystemExel Intl. · 19862cite it
  • K895770Exel Huber Infusion SetExel Intl. · 19902cite it
  • K895771Exel Spinal NeedlesExel Intl. · 19901cites it
  • K895768Exel Safelet CatheterExel Intl. · 19901cites it
  • K862491Exel Butterfly Scalp Vein SetExel Intl. · 19861cites it

What has FDA decided for it lately?

  • K992290Exel Injection Plug with CapExel Intl. · 2000
  • K963658Exel Avf Single NeedleExel Intl. · 1998
  • K963659Exel I.V. Administration SetExel Intl. · 1997
  • K926119Exel Huber Infusion Set Rotating WingExel Intl. · 1993
  • K904685Exel Huber Infusion Set Without Injection Site (Y)Exel Intl. · 1990
  • K903945Exel a-V Fistula SetExel Intl. · 1990
  • K895770Exel Huber Infusion SetExel Intl. · 19901 recall
  • K895769Exel Huber NeedleExel Intl. · 19901 recall

All 18 as Exel Intl. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K895769Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE…Dec 23, 2009
  • K895770Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R…Dec 23, 2009