Sheridan Catheter Corp.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Sheridan Catheter Corp.” (first 1982, latest 1993), across 15 product codes in 4 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 11 | 11 |
| FLL | Continuous Measurement Thermometer | 5 | 5 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 4 | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 2 | 2 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
Plus 5 more product codes.
Review panels
- Anesthesiology (24)
- Gastroenterology and Urology (6)
- General Hospital (6)
- General and Plastic Surgery (2)
Most recent Sheridan Catheter Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922894 | LAZER-TRACH TRACHEAL TUBE | BTR | 1993-05-07 | 325 |
| K897046 | LASER RESISTANT TRACHEAL TUBE | CBI | 1990-03-23 | 95 |
| K890823 | ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER | FLL | 1989-05-05 | 77 |
| K884765 | CLINICAL ELECTRONIC THERMOMETERS | FLL | 1989-02-16 | 94 |
| K882918 | KIM NASO-INTESTINAL TUBE | KNT | 1988-12-05 | 146 |
| K882127 | CLINICAL ELECTRONIC THERMOMETERS | FLL | 1988-08-04 | 76 |
| K881368 | CLINICAL ELECTONIC THERMOMETERS | FLL | 1988-07-13 | 22 |
| K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER | BZT | 1988-06-16 | 80 |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | GBS | 1988-05-18 | 15 |
| K880960 | NDYAG LASER TRACHEAL TUBE | BTR | 1988-04-29 | 52 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sheridan Catheter 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 Sheridan Catheter Corp.?
FDA lists 39 510(k) clearances under the applicant name “Sheridan Catheter Corp.” (first 1982, latest 1993), across 15 product codes in 4 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 Sheridan Catheter Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sheridan Catheter Corp. is 39 days.
Which FDA product codes appear under Sheridan Catheter Corp.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 11); FLL (Continuous Measurement Thermometer, 5); BZT (Stethoscope, Esophageal, With Electrical Conductors, 4).
Next steps
- See all 39 Sheridan Catheter Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Sheridan Catheter 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.