Pari Respiratory Equipment, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Pari Respiratory Equipment, Inc.” (first 2009, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 222 days. Since 2017 the median was 222 days, against 238 days for all cleared 510(k)s in the same product codes. 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 | 1 | 243 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 501 |
| 2017 | 1 | 193 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 255 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 232 |
| 2024 | 0 | — |
| 2025 | 1 | 211 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pari Respiratory Equipment, Inc. took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 8 | 8 |
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
Review panels
- Anesthesiology (10)
Most recent Pari Respiratory Equipment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251572 | eRapid with eTrack System | CAF | 2025-12-19 | 211 |
| K223840 | eRapid Nebulizer System | CAF | 2023-08-11 | 232 |
| K191270 | Proneb Max | CAF | 2020-01-23 | 255 |
| K162785 | Velox Nebulizer System | CAF | 2017-04-14 | 193 |
| K150044 | O-PEP | BWF | 2016-05-27 | 501 |
| K112859 | ERAPID NEBULIZER SYSTEM | CAF | 2012-05-30 | 243 |
| K092560 | PARI SINUS | CAF | 2010-05-06 | 259 |
| K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | CAF | 2010-02-22 | 6 |
| K092918 | PARI VIOS | CAF | 2010-02-04 | 135 |
| K090829 | PARI PEP S | BWF | 2009-07-21 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Pari Respiratory Equipment, 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 Respiratory Equipment, 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 Innovative Manufacturers, 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 Respiratory Equipment, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Pari Respiratory Equipment, Inc.” (first 2009, latest 2025), 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 Respiratory Equipment, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pari Respiratory Equipment, Inc. is 222 days. Since 2017: 222 days, versus 238 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pari Respiratory Equipment, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 8); BWF (Spirometer, Therapeutic (Incentive), 2).
Next steps
- See all 10 Pari Respiratory Equipment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Pari Respiratory Equipment, 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 (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.