Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Insights, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940903 | TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES | Medical Insights, Inc. | 1994-04-14 | 49 | 0 |
| K940904 | KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE | Medical Insights, Inc. | 1994-04-14 | 49 | 0 |
| K940901 | NON-WOVEN SPONGE | Medical Insights, Inc. | 1994-03-31 | 35 | 0 |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | 1993-06-07 | 250 | 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