510(k) Report

FDA applicant

Secure Medical Products, Inc.

Whitwater, WI1 decision1996–19969 recalls

FDA records 1 decision for Secure Medical Products, Inc. (Whitwater, WI) in 1996: 1 510(k) clearance. All are in product code KPE (Container, I.V.). 9 recalls are 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 Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

8in 2018

2016: 12018: 8
2007high 8 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KPEContainer, I.V.1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K960581Secure Eva Dual Chamber Mixing BagSecure Medical Products, Inc. · 19961cites it

What has FDA decided for it lately?

  • K960581Secure Eva Dual Chamber Mixing BagSecure Medical Products, Inc. · 19969 recalls

The one decision as Secure Medical Products, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K960581SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 -…Sep 21, 2018Class II
  • K960581SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 -…Sep 21, 2018Class II
  • K960581SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 -…Sep 21, 2018Class II
  • K960581SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian…Sep 21, 2018Class II
  • K960581SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian…Sep 21, 2018Class II
  • K960581SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian…Sep 21, 2018Class II

Other applicant names beginning “Secure”

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

Secure Scientific Sdn Bhd 1Secure Medical, Inc. 1