Exco, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Exco, Inc.” (first 1981, latest 1985), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DQR | Cannula, Catheter | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Plus 4 more product codes.
Review panels
- Cardiovascular (6)
- Gastroenterology and Urology (5)
- General Hospital (5)
- Anesthesiology (3)
- General and Plastic Surgery (1)
Most recent Exco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844203 | ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 | KNT | 1985-01-02 | 64 |
| K844175 | ENTERNAL FEEDING TUBE-POLYURETHANE EF504 | KNT | 1985-01-02 | 69 |
| K844174 | FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI | KNT | 1984-12-07 | 43 |
| K832628 | VYGON THORACIC DRAINAGE-VARIOUS #'S | KDD | 1984-01-30 | 179 |
| K831802 | LIFE VAC #2191 & 2192 | LJS | 1984-01-11 | 222 |
| K833079 | CENTRACATH #130,135 & 137-HEMOCATH # | FOZ | 1983-12-29 | 111 |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | KRK | 1983-04-05 | 15 |
| K822879 | ENTERAL NUTRITION 1 | KNT | 1982-11-16 | 50 |
| K822836 | MICROFLEX-VENOFLUX | FPA | 1982-10-15 | 24 |
| K822691 | VYGON EPIDURAL ANAESTHESIA TRAY | CAZ | 1982-10-15 | 42 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Exco, 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 Exco, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Exco, Inc.” (first 1981, latest 1985), across 14 product codes in 5 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 Exco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exco, Inc. is 39 days.
Which FDA product codes appear under Exco, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 5); DQO (Catheter, Intravascular, Diagnostic, 2); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2).
Next steps
- See all 20 Exco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Exco, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.