FDA applicant
Pollogen, Ltd.
FDA records 18 decisions for Pollogen, Ltd. (Tel Aviv, IL) from 2011 to 2025: 18 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and PAY (Over-The-Counter Radiofrequency Coagulation…). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 12 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 Pollogen, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Pollogen, 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