Stanco Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Stanco Medical, Inc.” (first 1979, latest 1981), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 5 | 5 |
| LDF | Electrode, Pacemaker, Temporary | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DOR | Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep. | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DRI | Monitor, Line Isolation | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (15)
- General Hospital (2)
- Anesthesiology (1)
- Clinical Toxicology (1)
Most recent Stanco Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810643 | UNIVERSAL PACING ELECTRODE KIT | LDF | 1981-04-08 | 29 |
| K810642 | ATRIAL-VENTRICULAR PACING ELECTRODE KIT | LDF | 1981-04-08 | 29 |
| K802289 | PERICARDIOCENTESIS KIT | DOR | 1980-11-26 | 68 |
| K802288 | SWAN GANZ CATHETER PLACEMENT KIT | DYG | 1980-11-20 | 62 |
| K802287 | RIGHT ATRIAL LINE KIT | DQY | 1980-11-20 | 62 |
| K802259 | TRANSVENOUS PACEMAKER ELECTRODE KIT | LDF | 1980-10-23 | 37 |
| K802290 | REGIONAL INTRAVENOUS ANESTHESIA KIT | CAZ | 1980-10-17 | 28 |
| K802328 | DISP. TOUGY-BORST TYPE ADAPTOR W/PORT | DTZ | 1980-10-10 | 17 |
| K802327 | SHEATH DILATOR SET | DRE | 1980-10-10 | 17 |
| K802326 | PRESSURE MONITORING LINES | DRI | 1980-10-10 | 17 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stanco Medical, 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 Stanco Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Stanco Medical, Inc.” (first 1979, latest 1981), across 13 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 Stanco Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stanco Medical, Inc. is 18 days.
Which FDA product codes appear under Stanco Medical, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 5); LDF (Electrode, Pacemaker, Temporary, 3); CAZ (Anesthesia Conduction Kit, 1).
Next steps
- See all 19 Stanco Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Stanco Medical, 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.