Data / Medical devices / Cap, Device Disinfectant
Cap, Device Disinfectant (QBP): 16 FDA-registered makers in 4 countries
16 establishments in 4 countries are registered with the FDA to make Cap, Device Disinfectant (product code QBP, Class 2, 21 CFR 880.5440). 14 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on March 27, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QBP
- Device class
- 2
- Regulation
- 880.5440
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Mexico | 1 |
| Poland | 1 |
| China | 1 |
Makers of Cap, Device Disinfectant
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer | 4 | May 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 4 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 4 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 4 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Columbia, MO, United States | Manufacturer | 4 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 3 | March 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 3 | March 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Manufacturer, Repackager or relabeler | 2 | March 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Solventum Poland Manufacturing SP. ZO.O | Wroclaw Dolnoslaskie, Poland | Manufacturer | 2 | December 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | November 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson And Company | Columbus, NE, United States | Manufacturer | 1 | November 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Excelsior Medical LLC | Neptune, NJ, United States | Manufacturer | 1 | December 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Specification developer | 1 | March 6, 2020 | 0 | 1 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Repackager or relabeler, Specification developer | 1 | May 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plas-Tech Engineering, LLC | Lake Geneva, WI, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
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.