Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kerr Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
126 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091613 | TAKE 1 | Kerr Corp. | 2009-10-07 | 126 | 0 |
| K090292 | PREMISE MODIFIED | Kerr Corp. | 2009-04-03 | 57 | 0 |
| K081695 | DMC COMPOSITE | Kerr Corp. | 2008-08-12 | 56 | 0 |
| K072622 | STANDOUT 2 | Kerr Corp. | 2007-12-04 | 78 | 0 |
| K042888 | DEMETRON IDS CURING LIGHT | Kerr Corp. | 2004-11-10 | 22 | 0 |
| K031484 | STAND OUT | Kerr Corp. | 2003-07-03 | 52 | 0 |
| K014179 | DEMETRON LC | Kerr Corp. | 2002-02-04 | 46 | 0 |
| K010994 | TAKE ONE BITE MODIFIED | Kerr Corp. | 2001-04-23 | 20 | 0 |
| K001655 | PERMLASTIC 2 | Kerr Corp. | 2000-08-10 | 71 | 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