Upstream Peripheral Technologies: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Upstream Peripheral Technologies” (first 2012, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 173 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 146 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 213 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 264 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Upstream Peripheral Technologies took a median 238 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 3 | 3 |
| DYB | Introducer, Catheter | 1 | 1 |
| PDU | Catheter For Crossing Total Occlusions | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Upstream Peripheral Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211802 | GoBack Crossing Catheter | PDU | 2022-03-01 | 264 |
| K182937 | Upstream GoBack Crossing Catheter | DQY | 2019-05-23 | 213 |
| K120964 | UPSTREAM GR CATHETER | DQY | 2012-05-25 | 56 |
| K112887 | UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR | DYB | 2012-03-21 | 173 |
| K112886 | UPSTREAM SUPPORT CATHETER | DQY | 2012-02-23 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Upstream Peripheral Technologies.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Upstream Peripheral Technologies?
FDA lists 5 510(k) clearances under the applicant name “Upstream Peripheral Technologies” (first 2012, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Upstream Peripheral Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Upstream Peripheral Technologies is 173 days.
Which FDA product codes appear under Upstream Peripheral Technologies?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 3); DYB (Introducer, Catheter, 1); PDU (Catheter For Crossing Total Occlusions, 1).
Next steps
- See all 5 Upstream Peripheral Technologies clearances with predicates and recalls
- Run predicate analysis for product code DQY, Upstream Peripheral Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.