Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medigroup, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
141 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120130 | FALLER TROCAR | Medigroup, Inc. | 2012-05-21 | 125 | 0 |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSO | Medigroup, Inc. | 2007-08-31 | 127 | 0 |
| K070730 | FLEX-NECK ARC CATHETER | Medigroup, Inc. | 2007-07-03 | 110 | 0 |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Medigroup, Inc. | 2006-07-18 | 106 | 0 |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Medigroup, Inc. | 2003-09-17 | 141 | 0 |
| K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR | Medigroup, Inc. | 1998-02-27 | 81 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda