Data / Medical devices / United States / Brisar Industries Inc
Brisar Industries Inc: FDA-registered device maker in Paterson, NJ, United States, 3 510(k) clearances and 1 PMA approval
Brisar Industries Inc is registered with the FDA (registration 3003559457) in Paterson, NJ, United States. It lists 9 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated December 7, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003559457
- Address
- 76 Wood Street, Paterson, NJ, United States, 07524
- Owner or operator
- BRISAR/DELVCO PACKAGING SERVICES (9071034)
- Roles
- Repackager or relabeler
- First device listed
- February 4, 2015
- Registered through
- 2026
- Brand names listed
- 4K Score Specimen Collection Kit, Case Contact Lens, Dura Derm Sport, Exofin Mastic, GluGone, Hero Patch + Hydrate Kit, Hero Patch Icon Kit, Hero Ultimate Patch Pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Case, Contact Lens | LRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer | QRF | 3 | Repackager or relabeler | accessdata.fda.gov |
| Solvent, Adhesive Tape | KOX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 3, 2017 | K162746 | Ontex and other proprietary names | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
| June 25, 2004 | K032948 | ELASTIC SKIN LIQUID BANDAGE | KMF | Unknown | Medpak, LLC | accessdata.fda.gov |
| June 28, 1993 | K931620 | OPTI-FREE CONTACT LENS CASE | LRX | Substantially Equivalent | Alcon Laboratories | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 7, 2021 | P190022 | 4Kscore Test | QRF | 3 | July 25, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Bandage, Liquid
- All makers of Toothbrush, Manual
- All makers of Case, Contact Lens
- All makers of Dressing, Wound, Occlusive
Updated July 25, 2025. 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.