Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KYR — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833872 | SAV-A-LIMB | Sil-Med Corp. | 1984-02-04 | 88 | 0 |
| K810653 | VINYL ICE BAG | First Industries, Inc. | 1981-03-27 | 17 | 0 |
| K780608 | ICE BAG, VINYL | Abco Dealers, Inc. | 1978-06-06 | 57 | 0 |
| K760951 | DEVON COOL FACE | Devon Industries, Inc. | 1976-12-30 | 59 | 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