Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pancretec, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
167 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882102 | PROVIDER ONE INFUSION SYSTEM | Pancretec, Inc. | 1988-08-12 | 85 | 0 |
| K871806 | PROVIDER IV. MODEL 5000 INFUSION DEVICE | Pancretec, Inc. | 1987-10-22 | 167 | 0 |
| K844078 | PROVIDER PA 3000 INFUSION SYSTEM | Pancretec, Inc. | 1984-12-18 | 60 | 0 |
| K843463 | PROVIDER BAG SPIKE W/12 MICROBORE EXTEN | Pancretec, Inc. | 1984-10-11 | 36 | 0 |
| K841373 | PROVIDER IV MODEL 2000 INFUSIN SYS | Pancretec, Inc. | 1984-05-14 | 41 | 0 |
| K841017 | PROVIDER INFUSION SET | Pancretec, Inc. | 1984-04-30 | 52 | 0 |
| K841027 | PROVIDER SITE PREP & CHECK STRIP KIT | Pancretec, Inc. | 1984-04-16 | 35 | 0 |
| K833983 | PROVIDER U-100 INSULIN INFUSION SYS | Pancretec, Inc. | 1984-04-13 | 148 | 0 |
| K841018 | PANCRETEC PUMP CHECK | Pancretec, Inc. | 1984-04-05 | 27 | 0 |
| K841028 | PROVIDER CAP SET | Pancretec, Inc. | 1984-04-05 | 24 | 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