Data / Medical devices / United States / Innovations For Access, Inc.
Innovations For Access, Inc.: FDA-registered device maker in Hillsboro, OR, United States, 2 510(k) clearances
Innovations For Access, Inc. is registered with the FDA (registration 3004202080) in Hillsboro, OR, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 12, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004202080
- FEI number
- 1000126788
- Address
- 8531 NE Cornell Rd STE 800, Hillsboro, OR, United States, 97124
- Owner or operator
- INNOVATIONS FOR ACCESS, INC. (9058740)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 23, 2008
- Registered through
- 2026
- Brand names listed
- HemoBand HB-1M, HemoBand HB-NS, HemoBand HB-NSXL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Complaint file establishment, Manufacturer | 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 12, 2009 | K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | KOC | Substantially Equivalent | Innovations For Access, Inc. | accessdata.fda.gov |
| July 27, 1992 | K920614 | HEMO-BAND | KOC | Substantially Equivalent | Innovations IN Access, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2009. 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.