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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Resmed Corp — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

159 daysmedian FDA review time
319 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253553OrionResmed Corp2026-06-042020
K254104ResScan EssentialsResmed Corp2026-05-271590
K251889myAirResmed Corp2026-04-082920
K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp2025-12-051890
K250624myAirResmed Corp2025-05-28860
K241939EasyCare Tx 2Resmed Corp2024-09-27870
K241216myAirResmed Corp2024-09-261480
K200565GalapogosResmed Corp2021-01-173190
K140124S9 ELOUERAResmed Corp2014-05-121160
K113801VPAP ADAPTResmed Corp2012-05-251550
K111148S8 ASPEN WITH H4I PLUSResmed Corp2011-06-30690
K090490MIRAGE ECHOResmed Corp2009-05-06700
K030797S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT Resmed Corp2004-03-103630
K013843AUTOSET SPIRIT CPAP SYSTEMResmed Corp2002-07-162380
K013909S7 ELITE CP AP SYSTEMResmed Corp2002-07-082240
K974417SULLIVAN VPAP II ST-A NASAL VPAP SYSTEMResmed Corp1998-06-242120
K971260SULLIVAN HUMIDAIRE HEATED HUMIDIFIERResmed Corp1997-09-041530

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