Respironics California, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Respironics California, Inc.” (first 2002, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 367 |
| 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 8 | 8 |
| NOU | Continuous, Ventilator, Home Use | 2 | 2 |
| MNT | Sv70 Ventilator | 1 | 1 |
Review panels
- Anesthesiology (11)
Most recent Respironics California, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | CBK | 2012-01-13 | 367 |
| K110795 | V200 INTELLI-TRAK OPTION | CBK | 2011-08-19 | 150 |
| K102054 | V200 VENTILATOR | CBK | 2010-12-22 | 153 |
| K082660 | V60 VENTILATOR, MODEL V8000 | MNT | 2009-01-09 | 119 |
| K072450 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 | CBK | 2007-12-12 | 103 |
| K071212 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 | CBK | 2007-07-30 | 90 |
| K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 | CBK | 2005-07-08 | 53 |
| K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 | CBK | 2004-06-18 | 22 |
| K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 | NOU | 2004-03-16 | 78 |
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 | NOU | 2003-11-20 | 458 |
1 earlier clearances. See the full list in Caduvo.
Recalls
67 product recalls in 27 recall events; 5 initiated in the last five years. Most recent: 2022-02-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Respironics California, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00817297: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators (Completed, started 2009-01-17)
- NCT00817804: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators (Completed, started 2009-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Respironics, Inc. (173 510(k)s)
- Respironics Inc., Sleep & Home Respiratory Group (21 510(k)s)
- Respironics Novametrix, Inc. (11 510(k)s)
- Respironics New Jersey, Inc. (5 510(k)s)
- Respironics Georgia, Inc. (2 510(k)s)
- Respironics Healthscan, Inc. (2 510(k)s)
- Respironics Respiratory Drug Delivery (Uk) , Ltd. (2 510(k)s)
- Respironics Inc. (Dba Philips Respironics) (1 510(k)s)
- Respironics (Ireland) Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Respironics California, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Respironics California, Inc.” (first 2002, latest 2012), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Respironics California, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respironics California, Inc. is 103 days.
Which FDA product codes appear under Respironics California, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 8); NOU (Continuous, Ventilator, Home Use, 2); MNT (Sv70 Ventilator, 1).
Next steps
- See all 11 Respironics California, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Respironics California, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.