FDA applicant
United Consortium
FDA records 15 decisions for United Consortium (Valencia, CA) from 2014 to 2020: 15 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and PEB (Lubricant, Personal, Gamete, Fertilization…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “United Consortium, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided United Consortium’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like United Consortium’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