Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HMW · 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) |
|---|---|---|---|---|---|
| K911040 | INVOTEC MICROSCOPE DRAPE | Invotec International, Inc. | 1991-06-03 | 87 | 0 |
| K902763 | STERILE INSTRUMENT DRAPE | North American Sterilization & Packaging Co. | 1990-09-20 | 87 | 0 |
| K902851 | MICROSCOPE DRAPE | Medical Technique Instruments, Inc. | 1990-09-10 | 73 | 0 |
| K843890 | CUSTOM INSTRUMENT DRAPE | Lifestream Int'L, Inc. | 1984-10-26 | 24 | 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