FDA applicant

Xeridiem Medical Devices, A Spectrum Plastics Group Company

Tucson, AZ2 decisions2018–20230 recalls

FDA records 2 decisions for Xeridiem Medical Devices, A Spectrum Plastics Group Company (Tucson, AZ) from 2018 to 2023: 2 510(k) clearances. All are in product code PIF (Gastrointestinal Tubes With Enteral Specific…). Its devices cite 2 predicates, 1 of them its own earlier devices. 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 Xeridiem Medical Devices, A Spectrum Plastics Group Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Xeridiem Medical Devices, A Spectrum Plastics Group Company by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xeridiem Medical Devices, A Spectrum…’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

Other applicant names beginning “Xeridiem”

FDA records each applicant name separately; these may or may not be the same firm.

Xeridiem Medical Devices 3 Xeridiem (Formerly Mri) 2

Xeridiem Medical Devices, A Spectrum Plastics Group Company

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Xeridiem”