FDA applicant

Solopak Medical Products, Inc.

Libertyville, IL4 decisions1996–19970 recalls

FDA records 4 decisions for Solopak Medical Products, Inc. (Libertyville, IL) from 1996 to 1997: 4 510(k) clearances. Most are in product codes MEB (Pump, Infusion, Elastomeric) and FPA (Set, Administration, Intravascular). Its devices cite 4 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, general hospital panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Solopak Medical Products, Inc.’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 “Solopak”

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

Solopak Laboratories, Inc. 1

Solopak Medical Products, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Solopak”