FDA applicant

Enterix, Inc.

Edison, NJ3 decisions2001–20173 recalls

FDA records 3 decisions for Enterix, Inc. (Edison, NJ) from 2001 to 2017: 3 510(k) clearances. All are in product code KHE (Reagent, Occult Blood). 3 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, hematology panel, where it files most

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

FDA decisions per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Enterix, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?