Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Resmed Pty Ltd (Registration Number: 3004604967) · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia | Resmed Pty Ltd (Registration Number: 3004604967) | 2024-09-24 | 270 | 0 |
| K230476 | Oran Park Mask | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 | 239 | 0 |
| K223747 | Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 | 204 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda