Panamedix, Inc.: FDA clearances and approvals
Panamedix, Inc. has 6 FDA 510(k) clearances (first 1986, latest 1988), across 4 product codes in 2 review panels. 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Panamedix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871848 | NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP | KNT | 1988-02-03 | 267 |
| K871843 | TWO FLUID W/CHECK VALVE | FPA | 1987-07-21 | 70 |
| K871842 | TWO FLUID I.V. SETS | FPA | 1987-06-24 | 43 |
| K871841 | THREE FLUID I.V. SETS | FPA | 1987-06-24 | 43 |
| K865051 | GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP | FRN | 1987-02-10 | 48 |
| K864395 | LOW VOLUME EXTENSION SET | FPK | 1986-12-16 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Panamedix, 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 Panamedix, 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 Panamedix, Inc. have?
Panamedix, Inc. has 6 FDA 510(k) clearances (first 1986, latest 1988), across 4 product codes in 2 review panels.
How long does FDA take to clear Panamedix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Panamedix, Inc.'s cleared 510(k)s is 46 days.
What devices does Panamedix, Inc. make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 3); FPK (Tubing, Fluid Delivery, 1); FRN (Pump, Infusion, 1).
Has Panamedix, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Panamedix, Inc. Related entities may recall under other names.
Next steps
- See all 6 Panamedix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Panamedix, 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.