Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Respironics New Jersey, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | Respironics New Jersey, Inc. | 2011-08-09 | 189 | 0 |
| K100285 | LITETOUCH MASK | Respironics New Jersey, Inc. | 2010-06-29 | 148 | 0 |
| K072418 | OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER | Respironics New Jersey, Inc. | 2007-09-12 | 15 | 0 |
| K053203 | MYNEB NEBULIZER, MODEL RDD100 | Respironics New Jersey, Inc. | 2005-12-20 | 34 | 0 |
| K042655 | INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODE | Respironics New Jersey, Inc. | 2004-10-13 | 15 | 0 |
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