Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KER — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
45 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831922 | EMBEDDING RING | Polymer Technology Corp. | 1983-07-29 | 45 | 0 |
| K831900 | MACLEAN-FOGG, DISP. BASE MOLD | Polymer Technology Corp. | 1983-07-28 | 44 | 0 |
| K831333 | EMBEDDING RINGS | Surgipath Medical Industries, Inc. | 1983-05-25 | 30 | 0 |
| K831335 | DISPOSABLE BASE MOLD | Surgipath Medical Industries, Inc. | 1983-05-16 | 21 | 0 |
| K772149 | LANCER BIOPSY HOLDER | Sherwood Medical Industries | 1977-11-22 | 8 | 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