Promedic, Inc.: FDA clearances and approvals
Promedic, Inc. has 16 FDA 510(k) clearances (first 1995, latest 2014), across 13 product codes in 5 review panels. Median 510(k) review time: 88 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 323 |
| 2013 | 0 | — |
| 2014 | 1 | 302 |
| 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| FOG | Hood, Oxygen, Infant | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GBM | Catheter, Urethral | 1 | 1 |
| KCY | Tourniquet, Pneumatic | 1 | 1 |
Plus 3 more product codes.
Review panels
- Anesthesiology (6)
- Gastroenterology and Urology (5)
- General Hospital (3)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Promedic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131889 | EUM 100PRO | OSP | 2014-04-23 | 302 |
| K112318 | CLEARPATH 24 | OCX | 2012-06-29 | 323 |
| K072756 | NON-IV ADAPTER FOR INFANT NG TUBE | KNT | 2007-12-19 | 83 |
| K060497 | BABYAIR | CAF | 2006-07-11 | 137 |
| K060842 | REVJET TURBO | CAF | 2006-06-21 | 85 |
| K052903 | PEDIATRIC FEEDING TUBE | KNT | 2005-11-09 | 26 |
| K031409 | URINARY CATHETERS | GBM | 2003-06-17 | 43 |
| K024190 | FENESTRATED INFUSION CATHETER | FRN | 2003-03-17 | 88 |
| K023579 | GAS SAMPLING LINES | CCK | 2003-01-28 | 96 |
| K020005 | INFANT FEEDING TUBES | KNT | 2002-07-16 | 195 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Promedic, 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 Promedic, 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)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Promedic, Inc. have?
Promedic, Inc. has 16 FDA 510(k) clearances (first 1995, latest 2014), across 13 product codes in 5 review panels.
How long does FDA take to clear Promedic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Promedic, Inc.'s cleared 510(k)s is 88 days.
What devices does Promedic, Inc. make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 3); CAF (Nebulizer (Direct Patient Interface), 2); BSJ (Mask, Gas, Anesthetic, 1).
Has Promedic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Promedic, Inc. Related entities may recall under other names.
Next steps
- See all 16 Promedic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Promedic, 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.