Pari Holding Co.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Pari Holding Co.” (first 1994, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 5 | 5 |
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
Review panels
- Anesthesiology (8)
Most recent Pari Holding Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | BTI | 2001-03-13 | 181 |
| K983308 | RC CORNET, MODEL #44F50 | BWF | 1999-06-04 | 256 |
| K972042 | PARI PEP THERAPY SYSTEM | BWF | 1997-08-05 | 64 |
| K963924 | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 | CAF | 1996-12-10 | 71 |
| K962072 | PRONEB TURBO COMPRESSOR MODEL 38V0200 | CAF | 1996-08-21 | 85 |
| K960675 | WALKHALER PORTABLE COMPRESSOR MODEL 45F70 | CAF | 1996-05-17 | 87 |
| K935540 | PARI-MASTER MODIFICATION | CAF | 1995-03-17 | 486 |
| K944152 | PARI BABY | CAF | 1994-11-18 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Pari Holding Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Pari Holding Co. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pari Innovative Manufacturers, Inc. (10 510(k)s)
- Pari Respiratory Equipment, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pari Holding Co.?
FDA lists 8 510(k) clearances under the applicant name “Pari Holding Co.” (first 1994, latest 2001), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pari Holding Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pari Holding Co. is 88 days.
Which FDA product codes appear under Pari Holding Co.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 5); BWF (Spirometer, Therapeutic (Incentive), 2); BTI (Compressor, Air, Portable, 1).
Next steps
- See all 8 Pari Holding Co. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Pari Holding Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.