Data / Medical devices / United States / Q.I. Medical, Inc.
Q.I. Medical, Inc.: FDA-registered device maker in Grass Valley, CA, United States, 3 510(k) clearances
Q.I. Medical, Inc. is registered with the FDA (registration 2950467) in Grass Valley, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 13, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2950467
- FEI number
- 1000123689
- Address
- 13366 Grass Valley Avenue STE B, Grass Valley, CA, United States, 95945
- Owner or operator
- Q.I. MEDICAL, INC. (9004706)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- PALL HP1002, QT Micro System, SafeFill
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 13, 1995 | K950305 | QTMICRO(TM) SYSTEM | LHI | Substantially Equivalent | Q.I. Medical, Inc. | accessdata.fda.gov |
| September 6, 1994 | K941589 | SYRINGE FILTER DEVICES | FMF | Substantially Equivalent | Gelman Sciences, Inc. | accessdata.fda.gov |
| October 19, 1992 | K921031 | EDGE MEDICAL DISPENSING PIN | LHI | Substantially Equivalent | Edgewater Medical Center | accessdata.fda.gov |
Compare with other makers
Updated October 13, 1995. 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.