Kerberos Proximal Solutions, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kerberos Proximal Solutions, Inc.” (first 2003, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 96 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 | 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| QEZ | Aspiration Thrombectomy Catheter | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Kerberos Proximal Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062275 | RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 | QEZ | 2006-09-20 | 44 |
| K050130 | KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM | QEZ | 2005-05-13 | 112 |
| K041123 | RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 | DQO | 2004-08-26 | 118 |
| K041151 | KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES | DQY | 2004-07-22 | 80 |
| K041291 | RINSPIRATION SYSTEM | DQO | 2004-05-21 | 7 |
| K031485 | RINSPIRATION SYSTEM | DQO | 2003-09-25 | 136 |
Recalls
openFDA lists no recalls under a recalling firm named Kerberos Proximal Solutions, Inc..
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 Kerberos Proximal Solutions, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kerberos Proximal Solutions, Inc.” (first 2003, latest 2006), 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 Kerberos Proximal Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kerberos Proximal Solutions, Inc. is 96 days.
Which FDA product codes appear under Kerberos Proximal Solutions, Inc.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 3); QEZ (Aspiration Thrombectomy Catheter, 2); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 6 Kerberos Proximal Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Kerberos Proximal Solutions, 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.