Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IPG · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
24 daysmedian FDA review time
44 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024279 | NESS CHILDREN SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | 2003-02-05 | 44 | 0 |
| K790652 | TOGUARD | Togard, Inc. | 1979-04-04 | 0 | 0 |
| K781363 | CAST SHOE | Cutler Biomedical | 1978-08-14 | 7 | 0 |
| K780617 | EQUALIZER | Ballert Orthopedic Corp. | 1978-04-18 | 5 | 0 |
| K760575 | ROCKER-SOLE CAST SANDAL | Richard'S Medical Equip., Inc. | 1976-10-06 | 33 | 0 |
| K760578 | BALANCED CAST SOLE | Parke-Davis Co. | 1976-09-27 | 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