Mednext, Inc.: FDA clearances and approvals
Mednext, Inc. has 7 FDA 510(k) clearances (first 1993, latest 1998), across 7 product codes in 4 review panels. Median 510(k) review time: 64 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 |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | 1 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
| HBB | Motor, Drill, Pneumatic | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
Review panels
Most recent Mednext, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983092 | TRITON HUDSON CHUCK ATTACHMENT | HBB | 1998-11-06 | 64 |
| K972308 | MEDNEXT 1000 DRILL | GEY | 1997-08-20 | 61 |
| K970023 | MEDNEXT SURGICAL BUR | HWE | 1997-02-28 | 56 |
| K943108 | MEDNEXT MICRO-DRILL | ERL | 1994-08-17 | 49 |
| K935861 | MEDNEXT BUR | HBE | 1994-05-03 | 151 |
| K935584 | MEDNEXT BUR | EQJ | 1994-02-22 | 96 |
| K926547 | MEDNEXT 1000 BONE DISSECTING SYSTEM | HSZ | 1993-07-22 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Mednext, 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.
Frequently asked questions
How many FDA 510(k) clearances does Mednext, Inc. have?
Mednext, Inc. has 7 FDA 510(k) clearances (first 1993, latest 1998), across 7 product codes in 4 review panels.
How long does FDA take to clear Mednext, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mednext, Inc.'s cleared 510(k)s is 64 days.
What devices does Mednext, Inc. make?
Its most frequent FDA product codes are EQJ (Bur, Ear, Nose And Throat, 1); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 1); GEY (Motor, Surgical Instrument, Ac-Powered, 1).
Has Mednext, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mednext, Inc. Related entities may recall under other names.
Next steps
- See all 7 Mednext, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EQJ, Mednext, 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.