510(k) Report

FDA applicant

C. B. Dumont Company, Inc.

Newport, RI2 decisions1982–19861 recall

FDA records 2 decisions for C. B. Dumont Company, Inc. (Newport, RI) from 1982 to 1986: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMF (Syringe, Piston). 1 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 C. B. Dumont Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for C. B. Dumont Company, Inc. since 2007.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — C. B. Dumont Company, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C. B. Dumont Company, 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, Intravascular1decision
  • FMFSyringe, Piston1decision

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.

  • K821537Henke Disposable SyringeC. B. Dumont Company, Inc. · 19821cites it

What has FDA decided for it lately?

  • K854804Multiple I.V. SetsC. B. Dumont Company, Inc. · 1986
  • K821537Henke Disposable SyringeC. B. Dumont Company, Inc. · 19821 recall

All 2 as C. B. Dumont Company, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K821537Henke-Ject-2 part luer sterile single use syringes - used for intravenous…Jul 27, 2023Class II