Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Corpak Co. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
372 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935512 | CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE | Corpak Co. | 1996-08-29 | 1017 | 0 |
| K931921 | CORPAK GASTROSTOMY TUBE | Corpak Co. | 1995-06-09 | 784 | 0 |
| K932847 | CORPAK ENTERAL PUMP | Corpak Co. | 1994-06-17 | 372 | 0 |
| K902949 | CORPAK GRASPING FORCEPS | Corpak Co. | 1990-08-30 | 56 | 0 |
| K901501 | CORPAK GASTROSTOMY TUBE | Corpak Co. | 1990-06-11 | 73 | 0 |
| K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | Corpak Co. | 1988-09-21 | 72 | 8 |
| K853253 | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI | Corpak Co. | 1985-11-05 | 95 | 0 |
| K852792 | CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW | Corpak Co. | 1985-08-08 | 38 | 0 |
| K842257 | CORPAK URINARY DRAINAGE BAG | Corpak Co. | 1984-08-08 | 62 | 0 |
| K841819 | CORPAK FOLEY CATH TRAY W/16FR. TEFLON | Corpak Co. | 1984-07-19 | 78 | 0 |
| K840292 | URETHRAL CATH. TRAY W/BAG | Corpak Co. | 1984-03-16 | 52 | 0 |
| K832167 | CORPAK VTR 300 ENTERNAL PUMP | Corpak Co. | 1983-08-16 | 42 | 0 |
| K830965 | ENTERAL SOLUTION ADMIN. PUMP SET | Corpak Co. | 1983-04-18 | 21 | 0 |
| K821409 | CORPAK-ENTERAL FEEDING CONTAINER | Corpak Co. | 1982-05-24 | 10 | 0 |
| K821410 | CORPAK-MONITOR ENTERAL FEEDING CONTAIN | Corpak Co. | 1982-05-24 | 10 | 0 |
| K820952 | OPTI-MIST | Corpak Co. | 1982-04-29 | 23 | 0 |
| K821036 | ENTERNAL SOLUTION ADMIN. SET | Corpak Co. | 1982-04-26 | 13 | 0 |
| K810559 | OPTI- SYSTEM | Corpak Co. | 1981-03-17 | 14 | 0 |
| K810219 | PREFILLED HUMIDIFER | Corpak Co. | 1981-03-04 | 36 | 0 |
| K810218 | PREFILLED NEBULIZER | Corpak Co. | 1981-03-04 | 36 | 0 |
| K810217 | NEBULIZER HEATER | Corpak Co. | 1981-03-04 | 36 | 0 |
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