FDA applicant
Guardian Products Co., Inc.
FDA records 8 decisions for Guardian Products Co., Inc. (Mchenry, IL) from 1977 to 1992: 8 510(k) clearances. Most are in product codes IKX (Aid, Transfer) and ILS (Adaptor, Hygiene). 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 Guardian Products Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Guardian Products Co., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Guardian Products Co., 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) ReportOther applicant names beginning “Guardian”
FDA records each applicant name separately; these may or may not be the same firm.