Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Janin Group, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
232 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | Janin Group, Inc. | 2002-02-04 | 185 | 0 |
| K013017 | MEDIGROUP KEY TUBE | Janin Group, Inc. | 2001-12-06 | 90 | 0 |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | Janin Group, Inc. | 1999-06-25 | 88 | 0 |
| K970159 | FLEX-NECK PD CATHETER | Janin Group, Inc. | 1997-09-05 | 232 | 0 |
| K810512 | MEDISEAL CAMERA COVERS | Janin Group, Inc. | 1981-03-13 | 17 | 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