FDA applicant
Lutech Industries, Inc.
FDA records 4 decisions for Lutech Industries, Inc. (Ronkonkoma, NY) from 2014 to 2017: 4 510(k) clearances. Most are in product codes HEX (Colposcope (And Colpomicroscope)) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 1 predicate, 1 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 Lutech Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Lutech 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) Report