Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JGM — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
88 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895718 | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER | Data Medical Associates, Inc. | 1989-10-19 | 24 | 0 |
| K862300 | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT | Amresco, Inc. | 1986-07-29 | 42 | 0 |
| K831300 | MSI-NAK-50 TEST KIT | Medical Specialties, Inc. | 1983-07-18 | 88 | 0 |
| K810253 | SODIUM & POTASSIUM TEST KIT | Mallinckrodt Critical Care | 1981-02-10 | 11 | 0 |
| K771068 | TRIGLYCERIDE KIT | Environmental Chemical Specialties | 1977-07-12 | 29 | 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