FDA applicant
Palliare, Ltd.
FDA records 6 decisions for Palliare, Ltd. (Galway, IE) from 2020 to 2024: 6 510(k) clearances. Most are in product codes HIF (Insufflator, Laparoscopic) and FCX (Insufflator, Automatic Carbon-Dioxide For…). Since 2016 its 510(k)s took a median of 172 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 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 Palliare, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Palliare, 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