Catheter Connections, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Catheter Connections, Inc.” (first 2010, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 74 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 | 2 | 52 |
| 2013 | 1 | 27 |
| 2014 | 1 | 84 |
| 2015 | 1 | 235 |
| 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 |
|---|---|---|---|
| QBP | Cap, Device Disinfectant | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Catheter Connections, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142806 | DualCap | QBP | 2015-05-22 | 235 |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | QBP | 2014-11-19 | 84 |
| K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | QBP | 2013-01-22 | 27 |
| K123065 | CATHETER CONNECTIONS DUALCAP SOLO | QBP | 2012-12-14 | 74 |
| K113842 | CATHETER CONNECTIONS' DUALCAP SOLO | QBP | 2012-01-27 | 30 |
| K112985 | CATHETER CONNECTIONS' DUALCAP DUO | QBP | 2011-11-09 | 34 |
| K093229 | CATHETER CONNECTIONS DUALCAP | QBP | 2010-04-08 | 176 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-08-05.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Catheter Technology Corp. (13 510(k)s)
- Catheter Innovations, Inc. (8 510(k)s)
- Catheter Research, Inc. (8 510(k)s)
- Catheter Research C/O Burditt, Bowles & Radzius (8 510(k)s)
- Catheter Robotics, Inc. (2 510(k)s)
- Catheter Precision, Inc. (2 510(k)s)
- Catheter Sciences Co. (2 510(k)s)
- Catheter, LLC (1 510(k)s)
- Catheter Corp. of America (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Catheter Connections, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Catheter Connections, Inc.” (first 2010, latest 2015), across 1 product code 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 Catheter Connections, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catheter Connections, Inc. is 74 days.
Which FDA product codes appear under Catheter Connections, Inc.?
The most frequent FDA product codes under this applicant name are QBP (Cap, Device Disinfectant, 7).
Next steps
- See all 7 Catheter Connections, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QBP, Catheter Connections, Inc.'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.