510(k) K122404 ยท FPA Set, Administration, Intravascular
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
| Applicant | Repro-Med Systems, Inc. Dba Rms Medical Products, New York NY, US |
| Decision | Substantially Equivalent, May 6, 2013 |
| Received | Aug 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2019 | Repro-Med Systems, Inc. 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous
Safety Needle Sets"
Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the Terminated |
FPA | None listed |
| Jan 5, 2018 | Repro-Med Systems, Inc. HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS6 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.