Data / Medical devices / Netherlands / BD Kiestra B.V.
BD Kiestra B.V.: FDA-registered device maker in Drachten Fryslan, Netherlands, 3 510(k) clearances
BD Kiestra B.V. is registered with the FDA (registration 3010141591) in Drachten Fryslan, Netherlands. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 31, 2023. 1 recall event names it as the recalling firm. Registered through 2027. 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
- 3010141591
- Address
- Marconilaan 6, Drachten Fryslan, Netherlands, 9207 JC
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 23, 2004
- Registered through
- 2027
- Brand names listed
- BD BBL Sensi-Disc 12-Place Self-Tamping Dispenser, BD BBL Sensi-Disc 6-Place Self-Tamping Dispenser, BD BBL Sensi-Disc 8-Place Self-Tamping Dispenser, BD BBL Sensi-Disc Single Disc Dispenser, BD Calibrated Disposable Inoculating Loops, Blue, BD Calibrated Disposable Inoculating Loops, Green, BD Dispenstirs, BD Disposable Inoculating Needles, Violet and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 31, 2023 | K222563 | BD Kiestra IdentifA | QQV | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 4, 2023 | K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | QQY | Substantially Equivalent | Bd Kiestra B.V. | accessdata.fda.gov |
| November 3, 2021 | K191964 | BD Kiestra IdentifA | QQV | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | 98473 | Class II | Ongoing | BD Kiestra" ReadA; Catalog No.: 446948. | In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample inte | accessdata.fda.gov |
Compare with other makers
- All makers of Bath, Incubators/Water, All
- All makers of Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Device, General Purpose, Microbiology, Diagnostic
- All makers of Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- All makers of Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Updated March 27, 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.