Respironics New Jersey, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Respironics New Jersey, Inc.” (first 2004, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 | 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| NVP | Holding Chambers, Direct Patient Interface | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Respironics New Jersey, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | NVP | 2011-08-09 | 189 |
| K100285 | LITETOUCH MASK | CAF | 2010-06-29 | 148 |
| K072418 | OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER | CAF | 2007-09-12 | 15 |
| K053203 | MYNEB NEBULIZER, MODEL RDD100 | CAF | 2005-12-20 | 34 |
| K042655 | INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 | CAF | 2004-10-13 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Respironics New Jersey, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Respironics New Jersey, Inc. (a text match, not an official crosswalk):
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. (172 510(k)s)
- Respironics Inc., Sleep & Home Respiratory Group (21 510(k)s)
- Respironics California, Inc. (11 510(k)s)
- Respironics Novametrix, Inc. (7 510(k)s)
- Respironics Novametrix, LLC (4 510(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)
- Respironics , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Respironics New Jersey, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Respironics New Jersey, Inc.” (first 2004, latest 2011), across 2 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 New Jersey, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respironics New Jersey, Inc. is 34 days.
Which FDA product codes appear under Respironics New Jersey, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 4); NVP (Holding Chambers, Direct Patient Interface, 1).
Next steps
- See all 5 Respironics New Jersey, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Respironics New Jersey, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.