Clincal Instruments Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Clincal Instruments Corp.” (first 1977, latest 1991), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 122 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DQT | Occluder, Catheter Tip | 1 | 1 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| GBP | Catheter, Multiple Lumen | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
Review panels
Most recent Clincal Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902327 | EMBOLECTOMY CATHETER | DXE | 1991-02-25 | 277 |
| K860743 | CAROTID BYPASS SHUNT WITH SAMPLING ARM | DWF | 1986-05-28 | 90 |
| K860742 | CAROTID BYPASS SHUNT | DWF | 1986-05-28 | 90 |
| K852704 | TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT | HGM | 1985-11-26 | 153 |
| K844918 | OCCLUSION & OCCLUSION-IRRIGATION | DQT | 1985-08-05 | 229 |
| K821220 | MULTILUMEN INTRAVENOUS INFUSION CATHETER | GBP | 1982-07-09 | 73 |
| K790034 | INTRODUCERS | DYB | 1979-02-01 | 29 |
| K771043 | SWAN GANZ | DYG | 1977-12-20 | 194 |
Recalls
openFDA lists no recalls under a recalling firm named Clincal Instruments Corp..
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 Clincal Instruments Corp.?
FDA lists 8 510(k) clearances under the applicant name “Clincal Instruments Corp.” (first 1977, latest 1991), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Clincal Instruments Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clincal Instruments Corp. is 122 days.
Which FDA product codes appear under Clincal Instruments Corp.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2); DQT (Occluder, Catheter Tip, 1); DXE (Catheter, Embolectomy, 1).
Next steps
- See all 8 Clincal Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Clincal Instruments Corp.'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.