Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
40 daysmedian FDA review time
41 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K865100 | TISSUE-EQUIVALENT BREAST SIMULATOR | Computerized Imaging Reference Systems, Inc. | 1987-01-12 | 13 | 0 |
| K851812 | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 | Victoreen, Inc. | 1985-06-05 | 40 | 0 |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Radiation Measurements, Inc. | 1984-01-25 | 41 | 0 |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Radiation Measurements, Inc. | 1984-01-25 | 41 | 0 |
| K810254 | 1.5` FOCAL SPOT RESOLUTION PATTERN | Machlett Laboratories, Inc. | 1981-02-19 | 20 | 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