Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cleveland Tubing, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945314 | CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING | Cleveland Tubing, Inc. | 1994-11-18 | 17 | 0 |
| K940889 | CONNECTORS AND AIRWAY EXTENSIONS | Cleveland Tubing, Inc. | 1994-11-10 | 258 | 0 |
| K940890 | CORRUGATED TUBING | Cleveland Tubing, Inc. | 1994-11-10 | 289 | 0 |
| K932119 | CLEVELAND TUBING, INC. VENTILATOR HOSES | Cleveland Tubing, Inc. | 1993-06-23 | 51 | 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