Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
E. Benson Hood Laboratories, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
115 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983878 | CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE | E. Benson Hood Laboratories, Inc. | 1999-01-29 | 88 | 0 |
| K841350 | SALIVARY BYPASS TUBE | E. Benson Hood Laboratories, Inc. | 1984-07-26 | 115 | 0 |
| K841349 | ESOPHAGEAL TUBE | E. Benson Hood Laboratories, Inc. | 1984-07-23 | 112 | 0 |
| K841266 | MONTGOMERY TRACHEAL T-TUBE | E. Benson Hood Laboratories, Inc. | 1984-06-14 | 80 | 0 |
| K841347 | LARYNGEAL STENT | E. Benson Hood Laboratories, Inc. | 1984-05-02 | 30 | 0 |
| K841348 | UMBRELLA KEEL | E. Benson Hood Laboratories, Inc. | 1984-05-02 | 30 | 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