Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Respironics, Inc. — Predicate Candidate Screening
172 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
273 days90th percentile
172clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 | 60 | 0 |
| K231313 | Therapy Mask 3100 NC/SP | Respironics, Inc. | 2023-07-28 | 84 | 0 |
| K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021-08-24 | 155 | 0 |
| K210386 | Magneto Nasal Mask | Respironics, Inc. | 2021-07-12 | 153 | 1 |
| K202142 | Sleepware G3 | Respironics, Inc. | 2020-10-29 | 90 | 0 |
| K201439 | Ventilator, Non-continuous (Respirator) | Respironics, Inc. | 2020-09-25 | 116 | 0 |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020-07-10 | 134 | 0 |
| K183226 | Care Orchestrator Essence | Respironics, Inc. | 2019-10-18 | 332 | 0 |
| K183625 | SomnaPatch | Respironics, Inc. | 2019-10-18 | 296 | 0 |
| K181166 | Trilogy Evo | Respironics, Inc. | 2019-07-18 | 442 | 33 |
| K181170 | Trilogy Evo Universal | Respironics, Inc. | 2019-07-18 | 442 | 12 |
| K181053 | Care Orchestrator | Respironics, Inc. | 2019-01-04 | 259 | 0 |
| K161411 | Care Cycle Connect Application | Respironics, Inc. | 2017-02-17 | 273 | 0 |
| K151120 | Simple T Pediatric Nasal Mask | Respironics, Inc. | 2016-04-15 | 354 | 0 |
| K152356 | Sapphire | Respironics, Inc. | 2016-01-08 | 141 | 0 |
| K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015-09-18 | 191 | 0 |
| K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015-09-18 | 191 | 0 |
| K142988 | Sleepware G3 | Respironics, Inc. | 2015-03-16 | 151 | 0 |
| K140980 | TI NASAL MASK | Respironics, Inc. | 2015-02-10 | 300 | 1 |
| K142554 | Revolution Full Face Mask | Respironics, Inc. | 2015-01-09 | 120 | 1 |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | 2014-11-14 | 268 | 0 |
| K140268 | SIMPLE T YOUTH NASAL MASK | Respironics, Inc. | 2014-10-20 | 250 | 1 |
| K132168 | BRONCHOSCOPY ELBOW | Respironics, Inc. | 2013-11-20 | 131 | 0 |
| K131982 | REMSTAR AUTO A-FLEX HT | Respironics, Inc. | 2013-10-18 | 112 | 5 |
| K131994 | SOMNOLYZER 24X7 | Respironics, Inc. | 2013-10-17 | 111 | 0 |
| K130077 | REMSTAR SE | Respironics, Inc. | 2013-05-21 | 127 | 1 |
| K122847 | KANGAROO NASAL MASK | Respironics, Inc. | 2013-03-06 | 169 | 0 |
| K122111 | RESPIRONICS SIMPLYCLEAR DEVICE | Respironics, Inc. | 2012-12-31 | 167 | 0 |
| K121955 | COUGHASSIST T70 DEVICE | Respironics, Inc. | 2012-12-14 | 164 | 0 |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-12-14 | 196 | 3 |
| K122769 | REMSTAR SE | Respironics, Inc. | 2012-10-09 | 29 | 1 |
| K121631 | SIMPLE T NASAL MASK | Respironics, Inc. | 2012-10-05 | 123 | 1 |
| K120562 | PERFORMAX PEDIATRIC EE TOTAL FACE MASK | Respironics, Inc. | 2012-07-17 | 144 | 0 |
| K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK | Respironics, Inc. | 2012-07-10 | 130 | 0 |
| K120145 | SIMPLE T NASAL MASK | Respironics, Inc. | 2012-03-30 | 72 | 0 |
| K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-02-01 | 111 | 5 |
| K113068 | REMSTAR AUTO A-FLEX HT | Respironics, Inc. | 2011-12-16 | 60 | 2 |
| K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | Respironics, Inc. | 2011-11-04 | 126 | 0 |
| K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY | Respironics, Inc. | 2011-10-14 | 127 | 1 |
| K110405 | TRUBLUE NASAL MASK | Respironics, Inc. | 2011-06-06 | 112 | 0 |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | Respironics, Inc. | 2011-06-01 | 110 | 0 |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | 2011-04-05 | 180 | 8 |
| K103395 | PERFORMAX TOTAL FACE MASK | Respironics, Inc. | 2011-03-24 | 125 | 0 |
| K102465 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2011-03-24 | 209 | 1 |
| K110008 | GOLIFE NASAL MASK | Respironics, Inc. | 2011-02-17 | 45 | 0 |
| K102502 | GOLIFE NASAL MASK | Respironics, Inc. | 2010-12-22 | 112 | 0 |
| K101129 | ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK | Respironics, Inc. | 2010-09-16 | 147 | 0 |
| K101130 | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK | Respironics, Inc. | 2010-09-02 | 133 | 0 |
| K093905 | TRILOGY 202 VENTILATOR | Respironics, Inc. | 2010-05-12 | 141 | 3 |
| K093416 | TRILOGY 200 VENTILATOR | Respironics, Inc. | 2010-01-29 | 88 | 5 |
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