510(k) Report

FDA applicant

Secure Medical, Inc.

Mundelein, IL1 decision1993–19931 recall

FDA records 1 decision for Secure Medical, Inc. (Mundelein, IL) in 1993: 1 510(k) clearance. All are in product code KPE (Container, I.V.). 1 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Secure Medical, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Secure Medical, 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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Other applicant names beginning “Secure”

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