510(k) K130975 ยท QBP Cap, Device Disinfectant
SWABCAP AND SWABFLUSH
| Applicant | Excelsior Medical Corp., Washington DC, US |
| Decision | Substantially Equivalent, Dec 24, 2013 |
| Received | Apr 8, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2025 | MEDLINE INDUSTRIES, LP - Northfield SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL
Model no. EMZE010301 Open, Classified |
QBP | None listed |
| Jul 11, 2025 | ICU Medical, Inc. SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000 Open, Classified |
QBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.