Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NEA — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
134 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140644 | PROCEM | Ototronix, LLC | 2014-06-19 | 98 | 0 |
| K080032 | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation | 2008-02-28 | 52 | 0 |
| K060750 | STRYKER INJECTABLE CEMENT | Stryker Cmf | 2006-04-19 | 29 | 0 |
| K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | 2004-11-08 | 53 | 0 |
| K011338 | OTO-CEM | Ototech, Inc. | 2001-09-13 | 134 | 0 |
| K003567 | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. | 2001-02-12 | 84 | 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