Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JCO — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
69 daysmedian FDA review time
173 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955115 | VENOM TIEM REAGENT | Medical Diagnostic Technologies, Inc. | 1996-04-03 | 146 | 0 |
| K932787 | BATROXOBIN REAGENT | Behring Diagnostics, Inc. | 1993-11-29 | 173 | 0 |
| K896033 | FDP COLLECTION TUBES | Medical Diagnostic Technologies, Inc. | 1989-10-27 | 11 | 0 |
| K852519 | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-12 | 56 | 0 |
| K843207 | REPTILASE -PC | Bio/Data Corp. | 1984-10-23 | 69 | 0 |
| K840210 | REPTILASE-R HA35 | Wellcome Diagnostics | 1984-04-23 | 95 | 0 |
| K780355 | ATROXIN | Sigma Chemical Co. | 1978-04-18 | 46 | 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