Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FQL · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
54 daysmedian FDA review time
117 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944240 | SOFT SOCK | Silipos, Inc. | 1994-12-27 | 117 | 0 |
| K823789 | ELASTIC COMPRESSION ANKLET | Orthopaedic Resources Corp. | 1983-01-07 | 22 | 0 |
| K823350 | ELASTIC COMPRESSION ANKLET | Podiatry Products Corp. | 1982-12-03 | 24 | 0 |
| K821259 | VITASAN | Selomas, Inc. | 1982-06-23 | 54 | 0 |
| K821260 | VITOFIT | Selomas, Inc. | 1982-06-23 | 54 | 0 |
| K820484 | VENES CUSTON RX | Jung Products, Inc. | 1982-03-18 | 24 | 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