FDA applicant

Entracare Corp.

Lenexa, KS6 decisions1994–20090 recalls

FDA records 6 decisions for Entracare Corp. (Lenexa, KS) from 1994 to 2009: 6 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and LZH (Pump, Infusion, Enteral). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Entracare, LLC”.

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 Entracare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Entracare Corp.’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

Entracare Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?