Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRQ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
117 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963720 | TRACHEOSTOMY KIT | Grand Medical Products | 1996-11-27 | 72 | 0 |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Medcare Medical Group, Inc. | 1996-07-02 | 99 | 0 |
| K952925 | READY NURSE SYSTEM (RNS) TRACH CARE KIT | Contour Fabricators of Florida, Inc. | 1995-07-12 | 16 | 0 |
| K950851 | GENT-L-KARE TRACHEOSTOMY TRAYS | Premium Plastics, Inc. | 1995-06-21 | 117 | 0 |
| K871692 | TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 | Automatic Liquid Packaging, Inc. | 1987-06-01 | 33 | 0 |
| K862663 | TRACHEOSTOMY CARE TRAY | Welmed Systems, Inc. | 1986-07-30 | 16 | 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