510(k) Report

FDA applicant

Spiess Design, Inc.

Northbrook, IL4 decisions1979–19960 recalls

FDA records 4 decisions for Spiess Design, Inc. (Northbrook, IL) from 1979 to 1996: 4 510(k) clearances. Most are in product codes JCX (Apparatus, Suction, Ward Use, Portable…) and FRN (Pump, Infusion). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Spiess Design, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spiess Design, 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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