Pari Respiratory Equipment, Inc.
Midlothian, VA, US
PARI RESPIRATORY EQUIPMENT, INC. appears in FDA device records in Midlothian, VA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Pari Respiratory Equipment, Inc. between 2009 and 2025. The busiest year on record is 2010, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 3 |
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251572 | eRapid with eTrack System | CAF | Substantially Equivalent | |
| K223840 | eRapid Nebulizer System | CAF | Substantially Equivalent | |
| K191270 | Proneb Max | CAF | Substantially Equivalent | |
| K162785 | Velox Nebulizer System | CAF | Substantially Equivalent | |
| K150044 | O-PEP | BWF | Substantially Equivalent | |
| K112859 | ERAPID NEBULIZER SYSTEM | CAF | Substantially Equivalent | |
| K092560 | PARI SINUS | CAF | Substantially Equivalent | |
| K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | CAF | Substantially Equivalent | |
| K092918 | PARI VIOS | CAF | Substantially Equivalent | |
| K090829 | PARI PEP S | BWF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2954963 | 1000142942 | PARI RESPIRATORY EQUIPMENT, INC. | 2412 PARI Way, MIDLOTHIAN, VA 23112 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain