510(k) Report

FDA applicant

Superior Healthcare Group, Inc.

Cumberland, RI14 decisions1985–19937 recalls

FDA records 14 decisions for Superior Healthcare Group, Inc. (Cumberland, RI) from 1985 to 1993: 14 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KNT (Tubes, Gastrointestinal (And Accessories)). 7 recalls are linked to its devices, 1 Class I.

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 Superior Healthcare Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Superior Healthcare Group, Inc. since 2007.

Recalls per year

1in 2023

2022: 62023: 1, 1 Class I
2007high 6 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Superior Healthcare Group, 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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