Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IDZ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
16 daysmedian FDA review time
30 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863483 | CASSETTE EMBOSSEER | Surgipath Medical Industries, Inc. | 1986-09-16 | 7 | 0 |
| K862457 | LYNX EL MICROSCOPY TISSUE PROCESSOR | Australian Biomedical Corporation , Ltd. | 1986-07-16 | 16 | 0 |
| K833857 | MACLEAN-FOGG, TISSUE CASSETTES | Polymer Technology Corp. | 1983-12-02 | 25 | 0 |
| K831334 | TISSUE CASSETTES FOR PROCESSING-EM BED | Surgipath Medical Industries, Inc. | 1983-05-25 | 30 | 0 |
| K760623 | LANCER PARAPLAST HISTO PROCESS CASSETTE | Sherwood Medical Industries | 1976-09-27 | 14 | 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