Pancretec, Inc.: FDA clearances and approvals
Pancretec, Inc. has 10 FDA 510(k) clearances (first 1984, latest 1988), across 2 product codes in 1 review panel. Median 510(k) review time: 46 days.
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 |
|---|---|---|---|
| FRN | Pump, Infusion | 7 | 7 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
Review panels
- General Hospital (10)
Most recent Pancretec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882102 | PROVIDER ONE INFUSION SYSTEM | FRN | 1988-08-12 | 85 |
| K871806 | PROVIDER IV. MODEL 5000 INFUSION DEVICE | FRN | 1987-10-22 | 167 |
| K844078 | PROVIDER PA 3000 INFUSION SYSTEM | FRN | 1984-12-18 | 60 |
| K843463 | PROVIDER BAG SPIKE W/12 MICROBORE EXTEN | FPA | 1984-10-11 | 36 |
| K841373 | PROVIDER IV MODEL 2000 INFUSIN SYS | FRN | 1984-05-14 | 41 |
| K841017 | PROVIDER INFUSION SET | FRN | 1984-04-30 | 52 |
| K841027 | PROVIDER SITE PREP & CHECK STRIP KIT | FPA | 1984-04-16 | 35 |
| K833983 | PROVIDER U-100 INSULIN INFUSION SYS | FRN | 1984-04-13 | 148 |
| K841028 | PROVIDER CAP SET | FPA | 1984-04-05 | 24 |
| K841018 | PANCRETEC PUMP CHECK | FRN | 1984-04-05 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Pancretec, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Pancretec, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Pancretec, Inc. have?
Pancretec, Inc. has 10 FDA 510(k) clearances (first 1984, latest 1988), across 2 product codes in 1 review panel.
How long does FDA take to clear Pancretec, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pancretec, Inc.'s cleared 510(k)s is 46 days.
What devices does Pancretec, Inc. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 7); FPA (Set, Administration, Intravascular, 3).
Has Pancretec, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pancretec, Inc. Related entities may recall under other names.
Next steps
- See all 10 Pancretec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Pancretec, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.