FDA applicant
Healgen Scientific,, LLC
FDA records 27 decisions for Healgen Scientific,, LLC (Bellaire, TX) from 2012 to 2026: 27 510(k) clearances. Most are in product codes NGL (Test, Opiates, Over The Counter) and JXM (Enzyme Immunoassay, Benzodiazepine). Since 2016 its 510(k)s took a median of 50 days from receipt to decision, against 40 for FDA’s reviews in the same codes and years. Its devices cite 48 predicates, 29 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Healgen Scientific,, LLC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Healgen Scientific,, 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 “Healgen”
FDA records each applicant name separately; these may or may not be the same firm.