Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pari Respiratory Equipment, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
232 daysmedian FDA review time
501 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 | 211 | 0 |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023-08-11 | 232 | 0 |
| K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020-01-23 | 255 | 0 |
| K162785 | Velox Nebulizer System | Pari Respiratory Equipment, Inc. | 2017-04-14 | 193 | 0 |
| K150044 | O-PEP | Pari Respiratory Equipment, Inc. | 2016-05-27 | 501 | 0 |
| K112859 | ERAPID NEBULIZER SYSTEM | Pari Respiratory Equipment, Inc. | 2012-05-30 | 243 | 0 |
| K092560 | PARI SINUS | Pari Respiratory Equipment, Inc. | 2010-05-06 | 259 | 0 |
| K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | Pari Respiratory Equipment, Inc. | 2010-02-22 | 6 | 0 |
| K092918 | PARI VIOS | Pari Respiratory Equipment, Inc. | 2010-02-04 | 135 | 0 |
| K090829 | PARI PEP S | Pari Respiratory Equipment, Inc. | 2009-07-21 | 117 | 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