FDA applicant
Quality IN Flow, Ltd.
FDA records 5 decisions for Quality IN Flow, Ltd. (Kibutz Einat, IL) from 2016 to 2022: 5 510(k) clearances. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 4 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 Quality IN Flow, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2016high 2 (2017) · low 0 (2019)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Quality IN Flow, 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