510(k) Report

FDA applicant

Enteron, Inc.

Camp Hill, PA1 decision1988–19880 recalls

FDA records 1 decision for Enteron, Inc. (Camp Hill, PA) in 1988: 1 510(k) clearance. All are in product code NRH (System, Breath Measurement). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Enteron, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Enteron, 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