Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicinelodge, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
197 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072525 | ZIPKNOT, MODEL 1017-3000 | Medicinelodge, Inc. | 2007-10-05 | 28 | 0 |
| K051488 | MEDICINELODGE ZIPKNOT | Medicinelodge, Inc. | 2005-07-27 | 51 | 0 |
| K962705 | MLI MODULAR STAPLE | Medicinelodge, Inc. | 1996-10-01 | 81 | 0 |
| K961920 | CROSS PIN | Medicinelodge, Inc. | 1996-09-17 | 123 | 0 |
| K961905 | MEDICINELODGE, INC. SET SCREW | Medicinelodge, Inc. | 1996-08-06 | 82 | 0 |
| K962194 | MLI SOFT TISSUE SCREW & WASHER SYSTEM | Medicinelodge, Inc. | 1996-07-30 | 53 | 0 |
| K961025 | EXPANDED BODY SUTURE | Medicinelodge, Inc. | 1996-04-15 | 32 | 0 |
| K953350 | MLI INTERFERENCE SCREW | Medicinelodge, Inc. | 1996-01-30 | 197 | 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