FDA applicant
Resmed, Ltd.
FDA records 126 decisions for Resmed, Ltd. (San Diego, CA) from 1996 to 2026: 126 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and MNS (Ventilator, Continuous, Non-Life-Supporting). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 217 for FDA’s reviews in the same codes and years. Its devices cite 217 predicates, 195 of them its own earlier devices. 13 recalls are linked to its devices, 9 Class I.
FDA’s records also spell it “Resmed Corp”, “Resmed Pty , Ltd.”, “Resmed Sas”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Resmed, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Resmed, 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 “Resmed”
FDA records each applicant name separately; these may or may not be the same firm.