Pudenz-Schulte Medical Research Corp.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Pudenz-Schulte Medical Research Corp.” (first 1980, latest 1996), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 95 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 18 | 18 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 4 | 4 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 | 4 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 3 | 3 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| GWG | Endoscope, Neurological | 1 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
| GYK | Instrument, Shunt System Implantation | 1 | 1 |
Plus 3 more product codes.
Review panels
- Neurology (23)
- General Hospital (10)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent Pudenz-Schulte Medical Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960055 | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 | LJS | 1996-09-30 | 270 |
| K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER | LJS | 1995-12-18 | 89 |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT | JXG | 1995-09-18 | 181 |
| K934796 | IPI LOW PROFILE IMPORT | LJT | 1994-07-14 | 281 |
| K934167 | IPI DUAL LUMEN PORT | LJT | 1994-07-14 | 321 |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | GWG | 1994-05-03 | 116 |
| K934545 | PS MEDICAL DELTA BURR HOLE VALVE | JXG | 1994-04-28 | 218 |
| K930206 | PS MEDICAL IPI ACCESS KIT | LJT | 1994-02-25 | 406 |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | GYK | 1993-09-10 | 217 |
| K913412 | PS MEDICAL CSF-ACCESS DEVICE | JXG | 1993-03-30 | 608 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pudenz-Schulte Medical Research 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 Pudenz-Schulte Medical Research Corp.?
FDA lists 40 510(k) clearances under the applicant name “Pudenz-Schulte Medical Research Corp.” (first 1980, latest 1996), across 13 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 Pudenz-Schulte Medical Research Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pudenz-Schulte Medical Research Corp. is 95 days.
Which FDA product codes appear under Pudenz-Schulte Medical Research Corp.?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 18); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 4); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 4).
Next steps
- See all 40 Pudenz-Schulte Medical Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code JXG, Pudenz-Schulte Medical Research 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.