FDA applicant
Medline Industries, Inc.
FDA records 269 decisions for Medline Industries, Inc. (Mundelein, IL) from 1977 to 2026: 268 510(k) clearances and 1 De Novo grant. Most are in product codes FYA (Gown, Surgical) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 125 predicates, 34 of them its own earlier devices. 82 recalls are linked to its devices, 11 Class I.
FDA’s records also spell it “Medline Industries, LP”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medline Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
38in 2026
Class I Class II/III not classified
Planning a device like Medline Industries, 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 “Medline”
FDA records each applicant name separately; these may or may not be the same firm.