510(k) Report

FDA applicant

Intec Medical, Inc.

Blue Springs, MO17 decisions1980–19910 recalls

FDA records 17 decisions for Intec Medical, Inc. (Blue Springs, MO) from 1980 to 1991: 17 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and BYX (Tubing, Pressure And Accessories). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Intec Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Intec”

FDA records each applicant name separately; these may or may not be the same firm.