FDA applicant
Nitiloop, Ltd.
FDA records 4 decisions for Nitiloop, Ltd. (Netanya, IL) from 2015 to 2020: 4 510(k) clearances. All are in product code DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Nitiloop, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Nitiloop, 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