FDA applicant
Pixcell Medical Technologies, Ltd.
FDA records 3 decisions for Pixcell Medical Technologies, Ltd. (Yokneam Ilit, IL) from 2018 to 2024: 3 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). Since 2016 its 510(k)s took a median of 300 days from receipt to decision, against 270 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Pixcell Medical Technologies”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pixcell Medical Technologies, 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 2018.
Planning a device like Pixcell Medical Technologies, 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