510(k) Report

FDA applicant

Yankee Intl. Medical Research & Mfg., Ltd.

Manchese, NH1 decision1988–19880 recalls

FDA records 1 decision for Yankee Intl. Medical Research & Mfg., Ltd. (Manchese, NH) in 1988: 1 510(k) clearance. All are in product code FJB (Detector, Dialysate Level). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Yankee Intl. Medical Research & Mfg., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Yankee Intl. Medical Research & Mfg., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Yankee Intl. Medical Research & Mfg., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yankee Intl. Medical Research & Mfg.…’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