FDA applicant
Itamar Medical, Ltd.
FDA records 17 decisions for Itamar Medical, Ltd. (Caesarea, IL) from 2003 to 2026: 17 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 247 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 17 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Itamar Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Itamar Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Itamar Medical, 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 “Itamar”
FDA records each applicant name separately; these may or may not be the same firm.