Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pudenz-Schulte Medical Research Corp. — Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
281 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960055 | MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN | Pudenz-Schulte Medical Research Corp. | 1996-09-30 | 270 | 0 |
| K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER | Pudenz-Schulte Medical Research Corp. | 1995-12-18 | 89 | 0 |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT | Pudenz-Schulte Medical Research Corp. | 1995-09-18 | 181 | 29 |
| K934167 | IPI DUAL LUMEN PORT | Pudenz-Schulte Medical Research Corp. | 1994-07-14 | 321 | 0 |
| K934796 | IPI LOW PROFILE IMPORT | Pudenz-Schulte Medical Research Corp. | 1994-07-14 | 281 | 0 |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | Pudenz-Schulte Medical Research Corp. | 1994-05-03 | 116 | 0 |
| K934545 | PS MEDICAL DELTA BURR HOLE VALVE | Pudenz-Schulte Medical Research Corp. | 1994-04-28 | 218 | 0 |
| K930206 | PS MEDICAL IPI ACCESS KIT | Pudenz-Schulte Medical Research Corp. | 1994-02-25 | 406 | 0 |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Pudenz-Schulte Medical Research Corp. | 1993-09-10 | 217 | 0 |
| K913412 | PS MEDICAL CSF-ACCESS DEVICE | Pudenz-Schulte Medical Research Corp. | 1993-03-30 | 608 | 0 |
| K922419 | IPI IMPORT | Pudenz-Schulte Medical Research Corp. | 1992-11-20 | 183 | 0 |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | 1991-12-30 | 19 | 1 |
| K911382 | IPI ALGO-LINE CATHETER | Pudenz-Schulte Medical Research Corp. | 1991-07-18 | 112 | 0 |
| K911410 | PS MEDICAL BUTTON VALVE | Pudenz-Schulte Medical Research Corp. | 1991-06-28 | 88 | 0 |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | 1990-10-03 | 16 | 0 |
| K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE | Pudenz-Schulte Medical Research Corp. | 1990-08-08 | 43 | 1 |
| K900676 | CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT | Pudenz-Schulte Medical Research Corp. | 1990-04-03 | 50 | 0 |
| K896167 | PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR | Pudenz-Schulte Medical Research Corp. | 1989-12-21 | 57 | 0 |
| K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | Pudenz-Schulte Medical Research Corp. | 1988-02-11 | 101 | 0 |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR | Pudenz-Schulte Medical Research Corp. | 1988-02-11 | 101 | 29 |
| K873247 | CSF-FLOW CONTROL VALVE, ULTRA SMALL | Pudenz-Schulte Medical Research Corp. | 1987-09-18 | 35 | 0 |
| K871752 | CSF-CARDIAC/PERITONEAL CATHETER | Pudenz-Schulte Medical Research Corp. | 1987-05-22 | 14 | 0 |
| K864754 | BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR | Pudenz-Schulte Medical Research Corp. | 1986-12-22 | 17 | 0 |
| K862907 | P-S MEDICAL CSF-SIPHON CONTROL DEVICE | Pudenz-Schulte Medical Research Corp. | 1986-12-03 | 125 | 0 |
| K862303 | BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. | Pudenz-Schulte Medical Research Corp. | 1986-08-12 | 56 | 0 |
| K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM | Pudenz-Schulte Medical Research Corp. | 1984-05-25 | 205 | 0 |
| K832677 | P-S MEDICAL BERLIN VISADUCT KIT | Pudenz-Schulte Medical Research Corp. | 1983-12-08 | 121 | 0 |
| K831396 | P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT | Pudenz-Schulte Medical Research Corp. | 1983-08-12 | 105 | 0 |
| K831678 | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR | Pudenz-Schulte Medical Research Corp. | 1983-06-24 | 32 | 0 |
| K823503 | P-S CSF-VENTRICULAR CATHETER, FLANGED | Pudenz-Schulte Medical Research Corp. | 1983-03-09 | 105 | 0 |
| K823509 | P-S MED. LUMBO PERITONEAL & VENTRICULO- | Pudenz-Schulte Medical Research Corp. | 1982-12-16 | 20 | 0 |
| K820949 | P-S BERLIN VESSEL CLAMP | Pudenz-Schulte Medical Research Corp. | 1982-04-29 | 23 | 0 |
| K820474 | P-S SUCTION RESERVIOR | Pudenz-Schulte Medical Research Corp. | 1982-03-08 | 17 | 0 |
| K813377 | PS-ROUND SURG. DRAIN & CONNECTOR | Pudenz-Schulte Medical Research Corp. | 1982-01-05 | 35 | 0 |
| K803257 | CSG-FLOW CONTROL VALVE | Pudenz-Schulte Medical Research Corp. | 1981-01-22 | 30 | 0 |
| K802100 | INTRACRANIAL PRESSURING MONITORING SYST. | Pudenz-Schulte Medical Research Corp. | 1980-09-16 | 13 | 0 |
| K801442 | P-S SURGICAL DRAIN | Pudenz-Schulte Medical Research Corp. | 1980-07-14 | 24 | 0 |
| K801443 | P-S SUCTION RESERVOIR | Pudenz-Schulte Medical Research Corp. | 1980-07-14 | 24 | 0 |
| K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES | Pudenz-Schulte Medical Research Corp. | 1980-01-16 | 103 | 30 |
| K792005 | CSF-CARDIAC/PERITONEAL CATHETER | Pudenz-Schulte Medical Research Corp. | 1980-01-16 | 103 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda