FDA applicant
Hologic, Inc.
FDA records 138 decisions for Hologic, Inc. (Malborough, MA) from 1987 to 2026: 118 510(k) clearances, 2 De Novo grants and 18 original PMA approvals. Most are in product codes KGI (Densitometer, Bone) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 149 predicates, 66 of them its own earlier devices. 44 recalls are linked to its devices.
FDA’s records also spell it “Hologic”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hologic, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Hologic, 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 “Hologic”
FDA records each applicant name separately; these may or may not be the same firm.