FDA applicant

Spectrum Medsystems Corp.

Irvine, CA1 decision1996–19960 recalls

FDA records 1 decision for Spectrum Medsystems Corp. (Irvine, CA) in 1996: 1 510(k) clearance. All are in product code EYZ (System, Urine Drainage, Closed, For…). 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 Spectrum Medsystems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectrum Medsystems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spectrum Medsystems Corp.’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 “Spectrum”

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

Spectrum Medical, Ltd. 23 Spectrum Designs, Inc. 18 Spectrum X-Ray Corp. 9 Spectrum Dynamics Medical, Ltd. 8 Spectrum Spine, LLC 8 Spectrum Vascular 6 Spectrum Co. 3 Spectrum Medical Technologies, Inc. 3 Spectrum Diagnostic, Inc. 3 Spectrum Dynamics, Ltd. 3 Spectrum Antimicrobials, Inc. 1 Spectrum Antimicrobials, Inc. (Subsidiary of… 1

Spectrum Medsystems Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Spectrum”