FDA applicant
Eclipse Medcorp, LLC
FDA records 4 decisions for Eclipse Medcorp, LLC (The Colony, TX) from 2020 to 2022: 4 510(k) clearances. Most are in product codes QAI (Powered Microneedle Device) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 262 days from receipt to decision, against 226 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Eclipse Medcorp, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Eclipse Medcorp, LLC’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 “Eclipse”
FDA records each applicant name separately; these may or may not be the same firm.