Data / Medical devices / United States / Bioaccess, Inc.
Bioaccess, Inc.: FDA-registered device maker in Baltimore, MD, United States, 1 510(k) clearance
Bioaccess, Inc. is registered with the FDA (registration 1124621) in Baltimore, MD, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 1986. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1124621
- FEI number
- 1000513050
- Address
- 4000 Hudson ST., Baltimore, MD, United States, 21224
- Owner or operator
- BIOACCESS, INC. (9031105)
- Roles
- Specification developer
- First device listed
- April 22, 2004
- Registered through
- 2026
- Brand names listed
- BioAccess Marrow Collection System, BioAccess Traction Pin Kit, NGD-1000, Next Gen Driver, NGD-1005A, Next Gen Driver with chuck, SBT 1001, SBT 1003, SBT 1004), SMALL BONE TOOL (SBT 1000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Marrow Collection/Transfusion Kit | LWE | 2 | Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | 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 |
|---|---|---|---|---|---|---|
| October 20, 1986 | K863734 | STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS | HTY | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Marrow Collection/Transfusion Kit
- All makers of Pin, Fixation, Smooth
- All makers of Bur, Surgical, General & Plastic Surgery
Updated October 20, 1986. 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.