Medigroup: FDA clearances and approvals
Medigroup has 15 FDA 510(k) clearances (first 1983, latest 2012), across 4 product codes in 2 review panels. Median 510(k) review time: 110 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 125 |
| 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 5 | 5 |
| FKX | System, Peritoneal, Automatic Delivery | 5 | 5 |
| HET | Laparoscope, Gynecologic (And Accessories) | 4 | 4 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | 1 | 1 |
Review panels
Most recent Medigroup 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120130 | FALLER TROCAR | FJS | 2012-05-21 | 125 |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | FJS | 2007-08-31 | 127 |
| K070730 | FLEX-NECK ARC CATHETER | FJS | 2007-07-03 | 110 |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | FJS | 2006-07-18 | 106 |
| K031351 | FLEX-NECK PD CATHETER, INFANT | FJS | 2003-09-17 | 141 |
| K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR | FKO | 1998-02-27 | 81 |
| K823294 | MEDIGROUP LS-110 LIGHT SOURCE | HET | 1983-05-09 | 185 |
| K823297 | ST-610 NEEDLESCOPE STERILIZATION TRAY | HET | 1983-05-06 | 182 |
| K823295 | MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& | HET | 1983-05-06 | 182 |
| K823293 | MEDIGROUP LG-102 LIGHT GUIDE | HET | 1983-05-05 | 181 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medigroup.
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 Medigroup have?
Medigroup has 15 FDA 510(k) clearances (first 1983, latest 2012), across 4 product codes in 2 review panels.
How long does FDA take to clear Medigroup's 510(k)s?
The median time from FDA receipt to decision across Medigroup's cleared 510(k)s is 110 days.
What devices does Medigroup make?
Its most frequent FDA product codes are FJS (Catheter, Peritoneal, Long-Term Indwelling, 5); FKX (System, Peritoneal, Automatic Delivery, 5); HET (Laparoscope, Gynecologic (And Accessories), 4).
Has Medigroup had device recalls?
openFDA lists no recalls under a recalling firm name matching Medigroup. Related entities may recall under other names.
Next steps
- See all 15 Medigroup clearances with predicates and recalls
- Run predicate analysis for product code FJS, Medigroup'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.