Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FCF · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
382 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070759 | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | Vidacare Corporation | 2007-05-21 | 62 | 0 |
| K062833 | POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM | Vidacare Corporation | 2006-11-30 | 70 | 0 |
| K984168 | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE | United States Endoscopy Group, Inc. | 1999-12-07 | 382 | 0 |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Intl. Medical, Inc. | 1992-01-10 | 57 | 0 |
| K911155 | OVAL CUP BIOPSY FORCEP | Endovations | 1991-08-07 | 145 | 0 |
| K843477 | PHARMA-PLAST RECTAL TIP | Zimmar Consulting , Ltd. | 1984-12-05 | 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