Pari Innovative Manufacturers, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Pari Innovative Manufacturers, Inc.” (first 2002, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 44 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) | 8 | 8 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
Review panels
- Anesthesiology (10)
Most recent Pari Innovative Manufacturers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072670 | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER | CAF | 2007-12-13 | 83 |
| K072982 | PARI HYDRATE V | BTT | 2007-11-29 | 37 |
| K070498 | HYPER SAL | CAF | 2007-04-26 | 65 |
| K070107 | PARI HYDRATE G | BTT | 2007-02-23 | 43 |
| K062158 | LC SPRINT STAR | CAF | 2006-08-28 | 31 |
| K061381 | LC STAR WITH NASAL ADAPTER | CAF | 2006-06-02 | 15 |
| K060357 | TREK S NEBULIZER COMPRESSOR | CAF | 2006-04-05 | 51 |
| K060399 | LC SPRINT NEBULIZER | CAF | 2006-03-02 | 15 |
| K033833 | EFLOW ELECTRONIC INHALER/NEBULIZER | CAF | 2004-05-05 | 147 |
| K020944 | VORTEX VALVED HOLDING CHAMBER | CAF | 2002-05-09 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Pari Innovative Manufacturers, Inc..
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 Innovative Manufacturers, Inc. (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 Respiratory Equipment, Inc. (10 510(k)s)
- Pari Holding Co. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pari Innovative Manufacturers, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Pari Innovative Manufacturers, Inc.” (first 2002, latest 2007), across 2 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 Innovative Manufacturers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pari Innovative Manufacturers, Inc. is 44 days.
Which FDA product codes appear under Pari Innovative Manufacturers, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 8); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 2).
Next steps
- See all 10 Pari Innovative Manufacturers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Pari Innovative Manufacturers, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.