Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IDL — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
24 daysmedian FDA review time
45 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863616 | KNIFE MAKER | Surgipath Medical Industries, Inc. | 1986-09-25 | 9 | 0 |
| K831921 | DISPOSABLE MICROTOME BLADES | Polymer Technology Corp. | 1983-07-29 | 45 | 0 |
| K831308 | DISPOSABLE MICROTOME BLADE | Surgipath Medical Industries, Inc. | 1983-05-16 | 24 | 0 |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | American Optical Corp. | 1981-12-29 | 21 | 0 |
| K801426 | TISSUE-TEK III MICROJECT DISP. BLADE SYS | Miles Laboratories, Inc. | 1980-07-28 | 41 | 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