FDA applicant
Smart Medical Systems, Ltd.
FDA records 9 decisions for Smart Medical Systems, Ltd. (Raanana, IL) from 2006 to 2022: 9 510(k) clearances. Most are in product codes FDF (Colonoscope And Accessories, Flexible/Rigid) and ODC (Endoscope Channel Accessory). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 250 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 7 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 Smart Medical Systems, Ltd.’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 2007.
Planning a device like Smart Medical Systems, Ltd.’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