Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical and Scientific Enterprises, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
336 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933131 | BISTAT 70/70-I ELECTROSURGICAL UNIT | Medical and Scientific Enterprises, Inc. | 1994-02-15 | 232 | 0 |
| K913881 | ENDOSTAT ELECTROSURGICAL UNIT | Medical and Scientific Enterprises, Inc. | 1991-11-01 | 64 | 0 |
| K895855 | PHOENIX | Medical and Scientific Enterprises, Inc. | 1990-01-22 | 112 | 0 |
| K882453 | POLYSCAN DIGITAL SCANNER | Medical and Scientific Enterprises, Inc. | 1988-11-23 | 162 | 0 |
| K861233 | DUAL PHOTON BONE DENSITOMETER | Medical and Scientific Enterprises, Inc. | 1987-03-03 | 336 | 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