Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Moss Tubes, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
113 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV | Moss Tubes, Inc. | 2019-06-14 | 113 | 0 |
| K990389 | MOSS GASTROSTOMY TUBE | Moss Tubes, Inc. | 1999-03-22 | 42 | 0 |
| K984628 | MODIFICATION OF MOSS P.E.G. TRAY | Moss Tubes, Inc. | 1999-03-17 | 77 | 0 |
| K984629 | MOSS TUBES, INC. NASAL TUBE - MARK IV | Moss Tubes, Inc. | 1999-03-02 | 62 | 0 |
| K984310 | MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE | Moss Tubes, Inc. | 1999-02-24 | 84 | 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