FDA applicant

Welcon, Inc.

Providence, RI8 decisions1981–200116 recalls

FDA records 8 decisions for Welcon, Inc. (Providence, RI) from 1981 to 2001: 8 510(k) clearances. Most are in product codes JOL (Catheter And Tip, Suction) and FTA (Light, Surgical, Accessories). Its devices cite 4 predicates, 0 of them its own earlier devices. 16 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, gastroenterology and urology panel, where it files most

How often FDA has decided Welcon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Welcon, Inc. since 2007.

Recalls per year

16in 2011

2007high 16 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Welcon, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?