Medical Concepts, Inc.: FDA clearances and approvals
Medical Concepts, Inc. has 5 FDA 510(k) clearances (first 1980, latest 2011), across 4 product codes in 4 review panels. Median 510(k) review time: 26 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 |
|---|---|---|---|
| FTS | Camera, Cine, Endoscopic, With Audio | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
Most recent Medical Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110659 | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM | MAX | 2011-09-13 | 190 |
| K940283 | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM | FET | 1994-09-28 | 252 |
| K883944 | MEC-1 VIDEO COMBO SYSTEM | FTS | 1988-09-28 | 9 |
| K883943 | CCM-1 VIDEO CAMERA SYSTEM | FTS | 1988-09-28 | 9 |
| K802564 | MEDICAL MAGNETIC TAPE RECORDER | DSH | 1980-11-12 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Concepts, 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 Medical Concepts, Inc. have?
Medical Concepts, Inc. has 5 FDA 510(k) clearances (first 1980, latest 2011), across 4 product codes in 4 review panels.
How long does FDA take to clear Medical Concepts, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical Concepts, Inc.'s cleared 510(k)s is 26 days.
What devices does Medical Concepts, Inc. make?
Its most frequent FDA product codes are FTS (Camera, Cine, Endoscopic, With Audio, 2); DSH (Recorder, Magnetic Tape, Medical, 1); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1).
Has Medical Concepts, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Concepts, Inc. Related entities may recall under other names.
Next steps
- See all 5 Medical Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTS, Medical Concepts, 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.