Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWN · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
187 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | Boston Medical Products, Inc. | 2009-09-14 | 147 | 0 |
| K000154 | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 | E. Benson Hood Lab, Inc. | 2000-03-29 | 70 | 0 |
| K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | Boston Medical Products, Inc. | 1996-08-09 | 29 | 0 |
| K896667 | LORENZ STENT | Walter Lorenz Surgical, Inc. | 1990-02-22 | 87 | 0 |
| K884810 | SILICONE LARYNGEAL STENT | Hood Laboratories | 1989-05-10 | 174 | 0 |
| K864936 | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL | Exmoor Plastics , Ltd. | 1987-04-27 | 132 | 0 |
| K853726 | LARYNGEAL | Hood Laboratories | 1986-03-12 | 187 | 0 |
| K842800 | MONTG. LARYNGEAL KEEL | Boston Medical Products, Inc. | 1984-08-02 | 16 | 0 |
| K842287 | MONTGOMERY LARYNGEAL STENT | Boston Medical Products, Inc. | 1984-06-27 | 12 | 0 |
| K841347 | LARYNGEAL STENT | 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