Respironics Inc., Sleep & Home Respiratory Group: FDA clearances and approvals
Respironics Inc., Sleep & Home Respiratory Group has 21 FDA 510(k) clearances (first 2007, latest 2010), across 6 product codes in 2 review panels. Median 510(k) review time: 96 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 10 | 10 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 4 | 4 |
| CBK | Ventilator, Continuous, Facility Use | 3 | 3 |
| MNR | Ventilatory Effort Recorder | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
- Anesthesiology (20)
- General Hospital (1)
Most recent Respironics Inc., Sleep & Home Respiratory Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092835 | COMFORTGEL NASAL MASK | BZD | 2010-02-12 | 150 |
| K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK | CBK | 2009-12-18 | 112 |
| K090539 | BIPAP AUTOSV ADVANCED | MNS | 2009-10-30 | 245 |
| K091191 | GAS TRANSFILL | CAW | 2009-10-23 | 183 |
| K091843 | COMFORT TWIN NASAL MASK | BZD | 2009-09-10 | 80 |
| K091066 | COMFORT TWIN NASAL MASK | BZD | 2009-09-03 | 142 |
| K091319 | REMSTAR AUTO A-FLEX | BZD | 2009-08-03 | 90 |
| K090484 | ALICE PDX | MNR | 2009-06-26 | 121 |
| K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK | BZD | 2009-05-29 | 29 |
| K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM | BZD | 2009-05-08 | 95 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Respironics Inc., Sleep & Home Respiratory Group.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Respironics Inc., Sleep & Home Respiratory Group have?
Respironics Inc., Sleep & Home Respiratory Group has 21 FDA 510(k) clearances (first 2007, latest 2010), across 6 product codes in 2 review panels.
How long does FDA take to clear Respironics Inc., Sleep & Home Respiratory Group's 510(k)s?
The median time from FDA receipt to decision across Respironics Inc., Sleep & Home Respiratory Group's cleared 510(k)s is 96 days.
What devices does Respironics Inc., Sleep & Home Respiratory Group make?
Its most frequent FDA product codes are BZD (Ventilator, Non-Continuous (Respirator), 10); MNS (Ventilator, Continuous, Non-Life-Supporting, 4); CBK (Ventilator, Continuous, Facility Use, 3).
Has Respironics Inc., Sleep & Home Respiratory Group had device recalls?
openFDA lists no recalls under a recalling firm name matching Respironics Inc., Sleep & Home Respiratory Group. Related entities may recall under other names.
Next steps
- See all 21 Respironics Inc., Sleep & Home Respiratory Group clearances with predicates and recalls
- Run predicate analysis for product code BZD, Respironics Inc., Sleep & Home Respiratory Group's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.