Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IKD — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
90 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | Oscor, Inc. | 2007-06-07 | 65 | 2 |
| K992372 | THE LEADAWAY | Therapy Equipment, Inc. | 1999-10-13 | 90 | 0 |
| K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | Physiometrix, Inc. | 1993-12-23 | 51 | 0 |
| K873361 | LIFE-SPAN CABLE | Chemfet Corp. | 1987-11-09 | 80 | 0 |
| K834583 | CLEAR LEADS-RADIOTRANSPARENT WIRES | Quinton, Inc. | 1984-01-30 | 32 | 0 |
| K800934 | R2 ESU CABLE-ADAPTER MODELS 160,161 | R2 Corp. | 1980-05-20 | 29 | 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