510(k) Report

FDA applicant

Inntec, Inc.

Stoughton, WI3 decisions2005–20050 recalls

FDA records 3 decisions for Inntec, Inc. (Stoughton, WI) in 2005: 3 510(k) clearances. Most are in product codes MQF (Catheter, Assisted Reproduction) and MQE (Needle, Assisted Reproduction). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Inntec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Inntec, 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