Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ellman International, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
290 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132949 | PELLEFIRM | Ellman International, Inc. | 2014-02-20 | 154 | 0 |
| K132665 | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - | Ellman International, Inc. | 2013-09-25 | 29 | 0 |
| K123366 | SURGITRON 4.0 DUAL RF S5-IEC | Ellman International, Inc. | 2013-07-12 | 254 | 0 |
| K071343 | ELLMAN NOBLE ALLOY ELECTRODES | Ellman International, Inc. | 2008-02-28 | 290 | 0 |
| K052241 | DISC-FX SYSTEM | Ellman International, Inc. | 2006-02-24 | 191 | 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