FDA applicant

Solopak Laboratories, Inc.

Elk Grove Village, IL1 decision1995–19950 recalls

FDA records 1 decision for Solopak Laboratories, Inc. (Elk Grove Village, IL) in 1995: 1 510(k) clearance. All are in product code LDH (Unnamed device). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Solopak Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Solopak Laboratories, 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 “Solopak”

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

Solopak Medical Products, Inc. 4

Solopak Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Solopak”