Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JJK · 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) |
|---|---|---|---|---|---|
| K863099 | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT | Abbott Laboratories | 1986-09-16 | 34 | 0 |
| K823196 | SPECIAL CONTROL SERUM FOR HDL-CHOLES | Boehringer Mannheim Corp. | 1982-11-29 | 34 | 0 |
| K802120 | HEPA-SHURE -L | Nuclear Medical Laboratories, Inc. | 1980-10-20 | 46 | 0 |
| K760975 | WEIL ONCOMETER (IL 186) | Instrumentation Laboratory CO | 1977-01-12 | 70 | 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