Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pari Innovative Manufacturers, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
147 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072670 | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER | Pari Innovative Manufacturers, Inc. | 2007-12-13 | 83 | 0 |
| K072982 | PARI HYDRATE V | Pari Innovative Manufacturers, Inc. | 2007-11-29 | 37 | 0 |
| K070498 | HYPER SAL | Pari Innovative Manufacturers, Inc. | 2007-04-26 | 65 | 0 |
| K070107 | PARI HYDRATE G | Pari Innovative Manufacturers, Inc. | 2007-02-23 | 43 | 0 |
| K062158 | LC SPRINT STAR | Pari Innovative Manufacturers, Inc. | 2006-08-28 | 31 | 0 |
| K061381 | LC STAR WITH NASAL ADAPTER | Pari Innovative Manufacturers, Inc. | 2006-06-02 | 15 | 0 |
| K060357 | TREK S NEBULIZER COMPRESSOR | Pari Innovative Manufacturers, Inc. | 2006-04-05 | 51 | 0 |
| K060399 | LC SPRINT NEBULIZER | Pari Innovative Manufacturers, Inc. | 2006-03-02 | 15 | 0 |
| K033833 | EFLOW ELECTRONIC INHALER/NEBULIZER | Pari Innovative Manufacturers, Inc. | 2004-05-05 | 147 | 0 |
| K020944 | VORTEX VALVED HOLDING CHAMBER | Pari Innovative Manufacturers, Inc. | 2002-05-09 | 45 | 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