FDA applicant
Spiess Design, Inc.
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
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.
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.
See the 510(k) Report