Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pari Holding Co. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
486 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | 2001-03-13 | 181 | 0 |
| K983308 | RC CORNET, MODEL #44F50 | Pari Holding Co. | 1999-06-04 | 256 | 0 |
| K972042 | PARI PEP THERAPY SYSTEM | Pari Holding Co. | 1997-08-05 | 64 | 0 |
| K963924 | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBU | Pari Holding Co. | 1996-12-10 | 71 | 0 |
| K962072 | PRONEB TURBO COMPRESSOR MODEL 38V0200 | Pari Holding Co. | 1996-08-21 | 85 | 0 |
| K960675 | WALKHALER PORTABLE COMPRESSOR MODEL 45F70 | Pari Holding Co. | 1996-05-17 | 87 | 0 |
| K935540 | PARI-MASTER MODIFICATION | Pari Holding Co. | 1995-03-17 | 486 | 0 |
| K944152 | PARI BABY | Pari Holding Co. | 1994-11-18 | 88 | 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