Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IYW · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944684 | POLYSCAN DIGITAL SCANNER | Mse Medizintechnik GmbH & Co. KG | 1995-05-15 | 235 | 0 |
| K895799 | RECTILINEAR SCANNER MODEL #187-270 | Atomic Products Corp. | 1990-02-01 | 126 | 0 |
| K882453 | POLYSCAN DIGITAL SCANNER | Medical and Scientific Enterprises, Inc. | 1988-11-23 | 162 | 0 |
| K780395 | IMAGER, BODY SECTION, RADIONUCLIDE | Union Carbide Corp. | 1978-03-31 | 18 | 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