Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ransom and Randolph — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
9 daysmedian FDA review time
22 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K781605 | R&R ABSORBENT POINTS | Ransom and Randolph | 1978-10-10 | 22 | 0 |
| K780399 | INSTRUMENT CLEANING BRUSH | Ransom and Randolph | 1978-03-17 | 4 | 0 |
| K780198 | PROPHY CUPS, R&R | Ransom and Randolph | 1978-02-16 | 9 | 0 |
| K780199 | PROPHY ANGLES, R&R | Ransom and Randolph | 1978-02-16 | 9 | 0 |
| K771347 | R&R ALSTON CARBIDE BURS | Ransom and Randolph | 1977-08-03 | 14 | 0 |
| K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | Ransom and Randolph | 1977-04-05 | 7 | 0 |
| K761067 | DENTSPLY DIE STONE | Ransom and Randolph | 1976-11-30 | 12 | 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