Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FGD · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
171 daysmedian FDA review time
406 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical, Inc. | 2023-06-16 | 171 | 0 |
| K905026 | DUAL FLEX NON-LATEX | Mmi, Inc. | 1991-12-18 | 406 | 0 |
| K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | E-Z-Em, Inc. | 1991-01-24 | 43 | 0 |
| K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | E-Z-Em, Inc. | 1990-11-27 | 69 | 0 |
| K884379 | MAGLINTE ENTEROCLYSIS CATHETER | Lafayette Pharmacal, Inc. | 1989-02-28 | 133 | 0 |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Mac Lee Medical Products | 1987-11-17 | 175 | 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