FDA applicant
Respironics New Jersey, Inc.
FDA records 5 decisions for Respironics New Jersey, Inc. (Cedar Grove, NJ) from 2004 to 2011: 5 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and NVP (Holding Chambers, Direct Patient Interface). Its devices cite 9 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Respironics New Jersey, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Respironics New Jersey, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Respironics”
FDA records each applicant name separately; these may or may not be the same firm.