Salt Creek Medical Technologies: FDA clearances and approvals
Salt Creek Medical Technologies has 8 FDA 510(k) clearances (first 1986, latest 1987), across 7 product codes in 3 review panels. Median 510(k) review time: 15 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| HFW | Clamp, Umbilical | 1 | 1 |
| HGE | Amniotome | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Salt Creek Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864683 | NEONATAL FEEDING KIT | KNT | 1987-04-17 | 136 |
| K871042 | URINE METER, 250CC | KNX | 1987-03-25 | 8 |
| K871087 | S.C.M.T. PERFORATOR | HGE | 1987-03-23 | 5 |
| K871075 | SCMT UMBILICAL CLAMP | HFW | 1987-03-23 | 5 |
| K864296 | S.C.T. MULTI PORT, INJECTION SITE | FPA | 1987-03-02 | 122 |
| K864682 | SALT CREEK P.I. TRAY | — | 1987-01-06 | 35 |
| K864692 | EXTENSION SETS | FPK | 1986-12-18 | 16 |
| K864693 | I.V. START KITS | — | 1986-12-16 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Salt Creek Medical Technologies.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Salt Creek Medical Technologies have?
Salt Creek Medical Technologies has 8 FDA 510(k) clearances (first 1986, latest 1987), across 7 product codes in 3 review panels.
How long does FDA take to clear Salt Creek Medical Technologies's 510(k)s?
The median time from FDA receipt to decision across Salt Creek Medical Technologies's cleared 510(k)s is 15 days.
What devices does Salt Creek Medical Technologies make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 1); FPK (Tubing, Fluid Delivery, 1); HFW (Clamp, Umbilical, 1).
Has Salt Creek Medical Technologies had device recalls?
openFDA lists no recalls under a recalling firm name matching Salt Creek Medical Technologies. Related entities may recall under other names.
Next steps
- See all 8 Salt Creek Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code FPA, Salt Creek Medical Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.