Data / Medical devices / United States / J. Knipper and Company, Inc.
J. Knipper and Company, Inc.: FDA-registered device maker in Charlestown, IN, United States, 1 510(k) clearance and 1 PMA approval
J. Knipper and Company, Inc. is registered with the FDA (registration 3014680791) in Charlestown, IN, United States. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 6, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014680791
- Address
- 1250 Patrol Road, Charlestown, IN, United States, 47111
- Owner or operator
- J. KNIPPER AND COMPANY, INC. (9053305)
- Roles
- Repackager or relabeler
- First device listed
- July 2, 2018
- Registered through
- 2026
- Brand names listed
- Becton, Dickinson and Company, Kaneka Corporation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lipoprotein, Low Density, Removal | MMY | 3 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 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 |
|---|---|---|---|---|---|---|
| July 6, 2016 | K161553 | BD SafeAssist | FMI | Substantially Equivalent | Becton, Dickinson and Company | 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 |
|---|---|---|---|---|---|---|
| February 21, 1996 | P910018 | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). | MMY | 37 | June 16, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Lipoprotein, Low Density, Removal
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated June 16, 2026. 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.