Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Effner and Spreine Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875260 | EFFNER CAUTERY INSTRUMENTS | Effner and Spreine Co. | 1988-06-06 | 167 | 0 |
| K874755 | EFFNER FE-EX* OROGASTRIC | Effner and Spreine Co. | 1988-04-06 | 140 | 0 |
| K872480 | KAHN-TACT U.S.A., EFF LARYNGOSCOPE | Effner and Spreine Co. | 1987-08-10 | 48 | 0 |
| K852014 | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA | Effner and Spreine Co. | 1985-08-07 | 90 | 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