Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Respironics Inc., Sleep & Home Respiratory Group · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
150 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092835 | COMFORTGEL NASAL MASK | Respironics Inc., Sleep & Home Respiratory Group | 2010-02-12 | 150 | 0 |
| K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-12-18 | 112 | 0 |
| K090539 | BIPAP AUTOSV ADVANCED | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-30 | 245 | 2 |
| K091191 | GAS TRANSFILL | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-23 | 183 | 0 |
| K091843 | COMFORT TWIN NASAL MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-10 | 80 | 0 |
| K091066 | COMFORT TWIN NASAL MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-03 | 142 | 0 |
| K091319 | REMSTAR AUTO A-FLEX | Respironics Inc., Sleep & Home Respiratory Group | 2009-08-03 | 90 | 1 |
| K090484 | ALICE PDX | Respironics Inc., Sleep & Home Respiratory Group | 2009-06-26 | 121 | 0 |
| K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-29 | 29 | 0 |
| K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-08 | 95 | 0 |
| K083526 | TRILOGY 100 VENTILATOR | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-13 | 105 | 8 |
| K090248 | BIPAP AUTOSV | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-04 | 30 | 4 |
| K082866 | REVOLUTIONFULL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-30 | 123 | 1 |
| K083874 | GALAXY | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-26 | 28 | 0 |
| K073600 | COMFORTGEL FULL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2008-04-25 | 126 | 0 |
| K072592 | PERFORMAX TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-19 | 96 | 0 |
| K072588 | PERFORMAX SE TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-18 | 95 | 0 |
| K071509 | BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2007-08-08 | 65 | 2 |
| K070180 | WALLABY 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-18 | 119 | 0 |
| K070328 | BIPAP SYNCHRONY WITH AVAPS | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-08 | 92 | 0 |
| K063830 | REMSTAR AFLEX CPAP SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2007-03-09 | 73 | 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