Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FCI · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
127 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895885 | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING | National-Standard Co. | 1990-02-09 | 127 | 0 |
| K894627 | BT-338N ELECTRONIC CLINICAL THERMOMETER | Integrated Display Technology, Ltd. | 1989-10-23 | 91 | 0 |
| K875119 | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | Advanced Diagnostic Medical Systems, Inc. | 1988-03-02 | 78 | 0 |
| K853104 | DISPOSABLE, STERILE BIOPSY PUNCH | August C. Stiefel Research Institute, Inc. | 1985-10-04 | 73 | 0 |
| K831317 | BIOPSY ATTACHMENT | Diasonics, Inc. | 1983-05-18 | 26 | 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