Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Benlan, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
403 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131183 | MED-RX ORAL/ENTERAL SYRINGE | Benlan, Inc. | 2014-06-03 | 403 | 0 |
| K120375 | MED-RX PATIENT DELIVERY SET | Benlan, Inc. | 2012-06-28 | 143 | 0 |
| K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR | Benlan, Inc. | 2011-12-23 | 87 | 0 |
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | Benlan, Inc. | 2010-12-13 | 276 | 1 |
| K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS | Benlan, Inc. | 2010-11-08 | 108 | 0 |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4 | Benlan, Inc. | 2001-11-28 | 272 | 1 |
| K990777 | MED-RX EXTENSION SETS | Benlan, Inc. | 1999-08-25 | 169 | 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