FDA applicant
Oridion Medical 1987, Ltd.
FDA records 19 decisions for Oridion Medical 1987, Ltd. (Jerusalem, IL) from 2001 to 2020: 19 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and MSQ (Test, Urea (Breath Or Blood)). Since 2016 its 510(k)s took a median of 249 days from receipt to decision, against 261 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 8 of them its own earlier devices. 35 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oridion Medical 1987, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
11in 2025
Class I Class II/III not classified
Planning a device like Oridion Medical 1987, 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) ReportOther applicant names beginning “Oridion”
FDA records each applicant name separately; these may or may not be the same firm.