Data / Medical devices / United States / Pari Respiratory Equipment, Inc.
Pari Respiratory Equipment, Inc.: FDA-registered device maker in Midlothian, VA, United States, 20 510(k) clearances
Pari Respiratory Equipment, Inc. is registered with the FDA (registration 2954963) in Midlothian, VA, United States. It lists 6 device types. The FDA files 20 510(k) clearances under its listings, the newest dated January 23, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2954963
- FEI number
- 1000142942
- Address
- 2412 PARI Way, Midlothian, VA, United States, 23112
- Owner or operator
- PRE HOLDING, INC. (9008012)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- March 7, 2005
- Registered through
- 2026
- Brand names listed
- Altera, Bubbles the Fish, ERAPID, Filter/Valve Set, Hyper-Sal, LC Disposable, LC Plus, LC Sprint and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ent | KCJ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2020 | K191270 | Proneb Max | CAF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| May 27, 2016 | K150044 | O-PEP | BWF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| May 30, 2012 | K112859 | ERAPID NEBULIZER SYSTEM | CAF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| May 6, 2010 | K092560 | PARI SINUS | CAF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| February 22, 2010 | K100380 | ALTERA NEBULIZER SYSTEM, MODEL 678G1002 | CAF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| February 4, 2010 | K092918 | PARI VIOS | CAF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| July 21, 2009 | K090829 | PARI PEP S | BWF | Substantially Equivalent | Pari Respiratory Equipment, Inc. | accessdata.fda.gov |
| April 26, 2007 | K070498 | HYPER SAL | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| August 28, 2006 | K062158 | LC SPRINT STAR | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| June 2, 2006 | K061381 | LC STAR WITH NASAL ADAPTER | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| April 5, 2006 | K060357 | TREK S NEBULIZER COMPRESSOR | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| March 2, 2006 | K060399 | LC SPRINT NEBULIZER | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| May 5, 2004 | K033833 | EFLOW ELECTRONIC INHALER/NEBULIZER | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| May 9, 2002 | K020944 | VORTEX VALVED HOLDING CHAMBER | CAF | Substantially Equivalent | Pari Innovative Manufacturers, Inc. | accessdata.fda.gov |
| March 13, 2001 | K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | BTI | Substantially Equivalent | Pari Holding Co. | accessdata.fda.gov |
| August 5, 1997 | K972042 | PARI PEP THERAPY SYSTEM | BWF | Substantially Equivalent | Pari Holding Co. | accessdata.fda.gov |
| December 10, 1996 | K963924 | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 | CAF | Substantially Equivalent | Pari Holding Co. | accessdata.fda.gov |
| March 17, 1995 | K935540 | PARI-MASTER MODIFICATION | CAF | Substantially Equivalent | Pari Holding Co. | accessdata.fda.gov |
| November 18, 1994 | K944152 | PARI BABY | CAF | Substantially Equivalent | Pari Holding Co. | accessdata.fda.gov |
| September 28, 1993 | K926455 | PARI FILTER/VALVE SET | CAF | Substantially Equivalent | Paul Ritzau Pari-Werk GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Spirometer, Therapeutic (Incentive)
- All makers of Tubing, Pressure And Accessories
- All makers of Applicator, Ent
- All makers of Compressor, Air, Portable
- All makers of Mask, Oxygen
Updated January 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.