Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Resmed, Ltd. — Predicate Candidate Screening
103 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
190 days90th percentile
103clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183512 | Moore Park Mask | Resmed, Ltd. | 2019-05-07 | 140 | 1 |
| K180497 | Scone Mask | Resmed, Ltd. | 2018-06-15 | 109 | 0 |
| K172875 | Astral 100/150 | Resmed, Ltd. | 2018-04-26 | 217 | 2 |
| K170924 | AirFit F20 | Resmed, Ltd. | 2018-01-03 | 280 | 2 |
| K171212 | AirFit N20 | Resmed, Ltd. | 2017-09-28 | 156 | 1 |
| K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017-01-19 | 232 | 0 |
| K160836 | Menai System | Resmed, Ltd. | 2016-12-15 | 265 | 0 |
| K161978 | AirFit N20 | Resmed, Ltd. | 2016-11-17 | 122 | 1 |
| K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV | Resmed, Ltd. | 2016-09-09 | 169 | 0 |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | 2016-09-09 | 101 | 0 |
| K152068 | Astral 100/150 | Resmed, Ltd. | 2016-05-13 | 294 | 1 |
| K153563 | AirFit F20 | Resmed, Ltd. | 2016-05-13 | 151 | 1 |
| K153673 | AirFit N20 | Resmed, Ltd. | 2016-05-02 | 133 | 0 |
| K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016-04-13 | 175 | 0 |
| K151901 | AirView | Resmed, Ltd. | 2015-11-05 | 118 | 0 |
| K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | Resmed, Ltd. | 2015-05-21 | 154 | 0 |
| K140279 | S9 GREENHILLS | Resmed, Ltd. | 2014-07-31 | 178 | 0 |
| K140159 | S9 WANDA VPAP ST | Resmed, Ltd. | 2014-06-17 | 146 | 0 |
| K132901 | AIRSOFT F15 | Resmed, Ltd. | 2014-06-09 | 266 | 0 |
| K133868 | ASTRAL VENTILATOR | Resmed, Ltd. | 2014-06-04 | 166 | 2 |
| K140054 | RESCAN | Resmed, Ltd. | 2014-05-16 | 127 | 0 |
| K132606 | S9 CRONULLA FOR HER | Resmed, Ltd. | 2014-01-13 | 146 | 0 |
| K132887 | AIRFIT N10 | Resmed, Ltd. | 2013-12-20 | 95 | 1 |
| K132371 | EASYCARE ONLINE | Resmed, Ltd. | 2013-11-22 | 115 | 0 |
| K132013 | SWIFT AIR | Resmed, Ltd. | 2013-10-21 | 112 | 0 |
| K123789 | SWIFT FX NANO | Resmed, Ltd. | 2013-03-29 | 109 | 0 |
| K123511 | S9 VPAP TX | Resmed, Ltd. | 2013-03-21 | 128 | 0 |
| K123557 | EASYCARE ONLINE | Resmed, Ltd. | 2013-03-14 | 115 | 0 |
| K123979 | QUATTRO AIR | Resmed, Ltd. | 2013-02-27 | 63 | 0 |
| K122324 | VPAP S-A | Resmed, Ltd. | 2012-11-13 | 104 | 0 |
| K121705 | GEO | Resmed, Ltd. | 2012-10-23 | 137 | 0 |
| K113714 | VPAP TX | Resmed, Ltd. | 2012-05-25 | 158 | 0 |
| K113780 | EASYCARE TX SYSTEM (CONNEXUNS) | Resmed, Ltd. | 2012-04-20 | 120 | 0 |
| K113288 | VPAP ST-A | Resmed, Ltd. | 2012-03-29 | 143 | 0 |
| K113815 | RESSCAN | Resmed, Ltd. | 2012-03-27 | 95 | 0 |
| K113127 | MIRAGE QUATTRO | Resmed, Ltd. | 2012-01-06 | 74 | 0 |
| K112914 | VPAP TX | Resmed, Ltd. | 2011-12-29 | 87 | 0 |
| K112489 | SWIFT FX BELLA | Resmed, Ltd. | 2011-12-07 | 100 | 0 |
| K112393 | TASMAN | Resmed, Ltd. | 2011-11-16 | 89 | 0 |
| K102586 | S9 VPAP ADAPT WITH H5I | Resmed, Ltd. | 2011-03-18 | 190 | 0 |
| K110444 | MIRAGE MICRO | Resmed, Ltd. | 2011-03-16 | 28 | 0 |
| K102513 | S9 VPAP ST WITH H5I | Resmed, Ltd. | 2011-01-05 | 126 | 0 |
| K102746 | MIRAGE FX | Resmed, Ltd. | 2010-12-28 | 96 | 0 |
| K102224 | PIXI PEDIATRIC MASK | Resmed, Ltd. | 2010-12-10 | 126 | 0 |
| K100772 | MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) | Resmed, Ltd. | 2010-06-09 | 83 | 0 |
| K093731 | VPAP III ST-A | Resmed, Ltd. | 2010-03-22 | 109 | 0 |
| K093684 | EASYCARE ONLINE | Resmed, Ltd. | 2010-02-26 | 88 | 0 |
| K092186 | VPAP TX | Resmed, Ltd. | 2009-12-22 | 154 | 0 |
| K092026 | EASYCARE TX, TX LINK | Resmed, Ltd. | 2009-10-02 | 88 | 0 |
| K091947 | S8 ASPEN WITH H4I PLUS | Resmed, Ltd. | 2009-09-28 | 90 | 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